Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

No
The device description details a standard ELISA assay and the performance studies analyze the clinical utility of the assay results. There is no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No.

The device is an in vitro diagnostic (IVD) test that measures a biomarker (NTx) to predict skeletal response and monitor therapeutic effects. It does not provide therapy or directly treat a disease.

Diagnostic

Yes

The device is a urinary assay that provides a quantitative measure of NTx as an indicator of human bone resorption, intended for predicting skeletal response to therapy and therapeutic monitoring of antiresorptive therapies. This directly aligns with the definition of a diagnostic device as it provides information for the diagnosis, treatment, or prevention of disease.

SaMD (Software as a Medical Device)

No

The device description clearly states that Osteomark is a competitive enzyme-linked immunosorbent assay (ELISA) and lists several physical reagents included in the kit. This indicates it is a hardware-based diagnostic test, not a software-only device.

IVD (In Vitro Diagnostic)

Yes, this device is an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use explicitly states that Osteomark is a "urinary assay that provides a quantitative measure of the excretion of crosslinked N-telopeptides of type I collagen (NTx) as an indicator of human bone resorption." This involves testing a sample (urine) taken from the human body to provide information about a physiological state (bone resorption).
Device Description: The device is described as a "competitive enzyme-linked immunosorbent assay (ELISA)" and lists various reagents included in a kit. This is a common format for in vitro diagnostic tests. The process involves analyzing a urine specimen using these reagents.
Performance Studies: The performance studies describe clinical trials where the device was used to measure NTx levels in urine samples from patients with specific conditions (postmenopausal women, osteoporosis, Paget's disease) and to monitor their response to therapy. This is consistent with the use of an IVD to aid in diagnosis, monitoring, or predicting response to treatment.
Key Metrics: The document provides key metrics like Sensitivity and Specificity, which are standard performance measures for diagnostic tests.

All of these points strongly indicate that Osteomark is designed to be used in vitro (outside the body) to examine a human specimen (urine) for diagnostic or monitoring purposes, which is the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Osteomark® is a urinary assay that provides a quantitative measure of the excretion of crosslinked N-telopeptides of type I collagen (NTx) as an indicator of human bone resorption. Elevated levels of urinary NTx indicate elevated human bone resorption. Measurement of NTx is intended for use in:

A. Predicting skeletal response (bone mineral density) to hormonal antiresorptive therapy in postmenopausal women

B. Therapeutic monitoring of:

1. anti-resorptive therapies in postmenopausal women
1. anti-resorptive therapies in individuals diagnosed with osteoporosis
1. anti-resorptive therapies in individuals diagnosed with Paget's disease of bone
1. estrogen-suppressing therapies

Product codes

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Device Description

Osteomark is a competitive enzyme-linked immunosorbent assay (ELISA) which utilizes a horseradish peroxidase labeled monoclonal antibody directed against the cross-linked Ntelopeptides (NTx) present in urine specimens. An Osteomark® kit is comprised of the following reagents:

Antigen Coated 96-Well Plate Calibrators: 1 nM BCE 30 nM BCE JUL 11 1996 100 nM BCE 300 nM BCE 1000 nM BCE 3000 nM BCE Antibody Conjugate Concentrate Antibody Conjugate Diluent Level I and Level II Urine Controls 30X Wash Concentrate Buffered Substrate Chromogen Reagent Stopping Reagent

The solid phase utilizes microwells onto which NTx has been adsorbed. NTx in the specimen or Calibrator competes with the solid phase NTx for antibody binding sites. The resulting amount of Antibody Conjugate bound to the solid phase is indirectly proportional to the amount of NTx in the specimen or Calibrator. The quantity of NTx in the specimen is determined from a standard calibration curve using reagents supplied in the kit. Assay values are standardized to an equivalent amount of bone collagen, and are expressed in nanomole bone collagen equivalents per liter (nM BCE). BCE reflects the amount of immunoreactive NTx, as measured by Ostcomark, liberated from human bone collagen following digestion with bacterial collagenase, as measured by hydroxyproline by high performance liquid chromatography (HPLC).

Mentions image processing

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Mentions AI, DNN, or ML

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Input Imaging Modality

Not Found

Anatomical Site

Bone (as indicated by "bone resorption" and "skeletal response")

Indicated Patient Age Range

Postmenopausal women, premenopausal women (for estrogen-suppressing therapies), individuals diagnosed with osteoporosis, individuals diagnosed with Paget's disease of bone.

Intended User / Care Setting

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Description of the training set, sample size, data source, and annotation protocol

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Description of the test set, sample size, data source, and annotation protocol

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Summary of Performance Studies

Reproducibility:

Intra-assay variability: Assessed using eight urine specimens tested in replicates of 10 by each of four operators. Average intra-assay variability estimate of 8% CV, with a range of 5-19% CV along the calibration curve.
Inter-assay variability: Assessed using three urine specimens tested in duplicate by one operator over 20 separate assay runs. Average inter-assay variability estimate of 4% CV, with a range of 3-5% CV along the calibration curve.

Antigen Recovery:

Evaluated by adding known amounts of NTx to each of three normal urine specimens.
Average antigen recovery of 105%, over an assay value range of 200-2500 nM BCE.

Dilutional Linearity:

Evaluated by performing serial dilutions of four urine specimens with high nM BCE values into a urine specimen with a low nM BCE value.
Correlation coefficients of r=0.999 to r=1.000 across an assay range of 44-2940 nM BCE.

Clinical Studies:

Use of Osteomark® in Therapeutic Monitoring of Hormonal Anti-Resorptive Therapy and in Predicting Skeletal Response (Bone Mineral Density) in Postmenopausal Women:
- Study type: Multi-center, randomized, prospective clinical trial.
- Sample size: 227 women (109 in HRT group, 118 in calcium group) completed 12-month study.
- Key results:
  - Osteomark® monitors the effect of therapy: Values in HRT Group decreased toward the premenopausal mean.
  - Baseline Osteomark® values and percent change from baseline to 6 months are predictive of the change in BMD and/or response to HRT.
  - Subjects in the highest quartile of Osteomark® values at baseline (67-188 nM BCE/mM creatinine), or with the greatest decrease from baseline to 6 months of therapy (-66 to -87%), showed the greatest gain in spine BMD in response to HRT.
  - Contingency table analysis showed that a >30% decrease at 6 months was significantly associated (p64 nM BCE/mM creatinine) had the greatest decrease in spine BMD.
  - Relative Risk analysis: A high baseline Osteomark® value (≥67 nM BCE/mM creatinine) indicated a 17.3 times higher risk of loss of spine BMD if not treated with HRT.
Use of Osteomark® to Monitor Estrogen Suppressing Therapy:
- Study type: Multi-center, non-randomized, prospective, longitudinal clinical trial.
- Sample size: Not explicitly stated, but 88 subjects mentioned for percentage change.
- Key results:
  - Mean Osteomark® value while estrogen suppressed was 61 nM BCE/mM creatinine, a 68% increase from baseline.
  - 63% (55/88) of subjects had a mean percent change from baseline of ≥30% (p=0.025).
  - Mean 68% increase from baseline Osteomark® correlated to a mean percent decrease at six months of -3.7% in lumbar spine (L1-L4) BMD (r = -0.46, p 40% decrease.
  - After 1 year of therapy, the mean percent change from baseline Osteomark® remained similar to 3 months (-65% ± 18).
  - In the calcium only group, Osteomark® values remained relatively constant, mean -13% ± 37 change from baseline at 1 year.

Key Metrics

Sensitivity for predicting response to HRT: 80% (95% C.I. 70%, 88%)
Specificity for predicting response to HRT: 59% (95% C.I. 36%, 79%)
Predictive Value Positive (PVP) (for a 30% change in Osteomark for predicting response)
- 60% Prevalence: 66.1%
- 70% Prevalence: 82.0%
- 80% Prevalence: 88.6%
- 90% Prevalence: 94.6%
- 99% Prevalence: 99.5%
Predictive Value Negative (PVN) (for a 30% change in Osteomark for predicting response)
- 60% Prevalence: 66.3%
- 70% Prevalence: 55.8%
- 80% Prevalence: 42.4%
- 90% Prevalence: 24.7%
- 99% Prevalence: 2.9%
Average intra-assay variability: 8% CV.
Average inter-assay variability: 4% CV.
Average antigen recovery: 105%.
Correlation coefficients for dilutional linearity: r=0.999 to == 1,000.
Lumbar spine (L1-L4) BMD correlation with Osteomark® for estrogen suppression: r = -0.46, p

Regulation Number and Section

§ 862.1400 Hydroxyproline test system.

(a)
Identification. A hydroxyproline test system is a device intended to measure the amino acid hydroxyproline in urine. Hydroxyproline measurements are used in the diagnosis and treatment of various collagen (connective tissue) diseases, bone disease such as Paget's disease, and endocrine disorders such as hyperparathyroidism and hyperthyroidism.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 862.9.

Summary

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Summary of Safety and Effectiveness

Osteomark is a competitive enzyme-linked immunosorbent assay (ELISA) which utilizes a horseradish peroxidase labeled monoclonal antibody directed against the cross-linked Ntelopeptides (NTx) present in urine specimens. An Osteomark® kit is comprised of the following reagents:

Antigen Coated 96-Well Plate Calibrators: 1 nM BCE 30 nM BCE JUL 11 1996 100 nM BCE 300 nM BCE 1000 nM BCE 3000 nM BCE Antibody Conjugate Concentrate Antibody Conjugate Diluent Level I and Level II Urine Controls 30X Wash Concentrate Buffered Substrate Chromogen Reagent Stopping Reagent

The solid phase utilizes microwells onto which NTx has been adsorbed. NTx in the specimen or Calibrator competes with the solid phase NTx for antibody binding sites. The resulting amount of Antibody Conjugate bound to the solid phase is indirectly proportional to the amount of NTx in the specimen or Calibrator. The quantity of NTx in the specimen is determined from a standard calibration curve using reagents supplied in the kit. Assay values are standardized to an equivalent amount of bone collagen, and are expressed in nanomole bone collagen equivalents per liter (nM BCE). BCE reflects the amount of immunoreactive NTx, as measured by Ostcomark, liberated from human bone collagen following digestion with bacterial collagenase, as measured by hydroxyproline by high performance liquid chromatography (HPLC).

10 SIDET Sin

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Intended Use of Osteomark®

Osteomark® is a urinary assay that provides a quantitative measure of the excretion of crosslinked N-telopeptides of type I collagen (NTx) as an indicator of human bone resorption. Elevated levels of urinary NTx indicate elevated human bone resorption. Measurement of NTx is intended for use in:

A. Predicting skeletal response (bone mineral density) to hormonal antiresorptive therapy in postmenopausal women

B. Therapeutic monitoring of:

1. anti-resorptive therapies in postmenopausal women
1. anti-resorptive therapies in individuals diagnosed with osteoporosis
1. anti-resorptive therapies in individuals diagnosed with Paget's disease of bone
1. estrogen-suppressing therapies

The measurement range of Osteomark is 20 to 3000 nM Bone Collagen Equivalents (BCE) of NTx.

Expected Values

Urine Collection:

A multi-center, cross-sectional study was conducted to determine the reference range for normal premenopausal women (mean age 36 years, range 25-49). Male reference range was determined from a study conducted at a large reference laboratory (mean age 46 years, range 24-71). The mean, standard deviation, and the mean ± 2 standard deviation ranges for these two populations are presented in Table 1 below.

Table 1 - Expected Osteomark® Values for Premenopausal Women and Men

| | Mean* | Std Dev | Range
(mean ± 2 std dev)* | N |
|-------|-------|---------|------------------------------|-----|
| Women | 35 | 15 | 5-65 | 258 |
| Men | 27 | 12 | 3-51 | 81 |

expressed as nanomoles BCE/millimole creatinine

rk® 510(k) Submission rex Insternational, Inc.

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In a separate study, the expected within-subject variability was determined from urine specimens from eight healthy subjects collected every 2-3 days over approximately 2 months. The average of the individual within-subject longitudinal variation was 19.3%. The average between-subject longitudinal variation was 38.3%.

Limitations of the Procedure

Lower Limit of Detection

The lower limit of detection of the Osteomark® assay is 20 nM BCE. This value represents a concentration which is greater than the value which can be distinguished from zero, and was calculated by subtracting 3 standard deviations optical density (A450-A630) from established variability of the InM BCE Calibrator. Assay precision below this value is insufficient for accurate results.

Interfering Substances

Common urine components and contaminants, as well as microbiological contaminants, that are known to interfere with many laboratory urine analyses were evaluated for an interfering effect with Osteomark®. The evaluations were performed by adding normal and excessive quantities of each potential inhibitor to normal urine specimens and analyzing for an effect on the final results. Results show that specimens obviously contaminated with whole blood or that have extensive hemolysis may show interference in the assay. These specimens should be avoided, and the specimen recollected.

Limitations of the Procedure

While Osteomarks is used as an indicator of bone resorption, use of this test has not been established to predict development of osteoporosis or future fracture risk. Use of this test has not been established in primary hyperparathyroidism or hyperthyroidism. When using Osteomark® to monitor therapy, results may be confounded in patients afflicted with clinical conditions known to affect bone resorption, e.g., metastases to bone. While an

omark® 510(k) Submission Onex International, Inc.

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Osteomarks value provides a measure of the level of bone resorption, a single Osteomark® value can not provide the rate of bone resorption as reported results do not contain a measure of time. Osteomark@ results should be interpreted in conjunction with clinical findings and other diagnostic results.

Performance Characteristics

Reproducibility

Assay reproducibility was evaluated for intra-assay variability of normal urine specimens across the range of the calibration curve.

Intra-assay variability, or within assay precision, was assessed using eight urine specimens tested in replicates of 10 by each of four operators. Results demonstrate an average intraassay variability estimate of 8% CV, with a range of 5-19% CV along the calibration curve.

Inter-assay variability, or assay to assay precision, was assessed using three urine specimens tested in duplicate by one operator over 20 separate assay runs. Results demonstrate an average interassay variability estimate of 4% CV. with a range of 3-5% CV along the calibration curve.

Antigen Recovery

Antigen recovery was evaluated by adding known amounts of NTx to each of three normal urine specimens. Recovery represented the observed assay value of the "spiked" specimens, calculated as a percent of the expected urine value (baseline urine value plus added antigen value). Results demonstrate an average antigen recovery of 105%, over an assay value range of 200-2500 nM BCE.

toomark@ 510(k) Submission tex International, Inc.

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Dilutional Linearity

Dilutional linearity was evaluated by performing serial dilutions of four urine specimens with high nM BCE values into a urine specimen with a low nM BCE value. Results demonstrated correlation coefficients of r=0.999 to == 1,000 across an assay range of 44-2940 nM BCE.

Clinical Studies

Use of Osteomark® in Theraneutic Monitoring of Hornons) Anti-Resorntive Therany and in Predicting Skeletal Response (Bone Mineral Density) in Postmenonausal Women

A multi-center, randomized, prospective clinical trial was conducted to determine the ability of the Osteomark® assay to monitor the effect of hormonal anti-resorptive therapy on bone resorption in early postmenopausal women, and to predict response to hormone replacement therapy (HRT). Subjects were randomized to estrogen (0.625 mg) and medroxyprogesterone (2.5 - 5 mg cyclic or continuous) plus a daily 500 mg calcium supplement (HRT group), or a daily 500 mg calcium supplement only (calcium group). A total of 227 women, 109 in the HRT group and 118 in the calcium group, completed the 12 month study (Campodarve et.al., 1995).

The following data support the clinical utility of Osteomark® to monitor hormonal anti-resorptive therapy in early postmenopausal women and to predict changes in bone mineral density (BMD) measured by dual energy x-ray absorptiometry (DEXA) in response to HRT, thereby identifying who will receive the greatest benefit from such therapy, and to identify those at risk for bone loss.

Osteomark® monitors the effect of therapy

Figure I provides the Osteomarkes values throughout the study. Figure 2 provides the percent change from baseline Osteomark® throughout the study.

· The baseline Osteomark® value in the two groups combined was 59 + 2.1 (mean ± sem) nM BCB/mM creatinine.
· In the HRT Group, the values decrease toward the premenopausal mean.

Oncomand 510(k) Submission Ostex International, Inc.

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Image /page/5/Figure/0 description: The image is a title for a figure. The title reads "Figure 1: Osteomark® Values Throughout the Study". The title is written in a bold, serif font.

Image /page/5/Figure/1 description: This image shows a graph titled "HET GROUP". The x-axis shows the time in terms of "Baseline", "1 Month", "4 Month", and "1 Year". The y-axis shows a scale from 0 to 200. The graph shows the distribution of data points at each time point.

Image /page/5/Figure/2 description: This image is a bar graph titled "CALCIUM GROUP". The x-axis represents time intervals: Newborn, 1 Month, 6 Months, and 1 Year. The y-axis represents a numerical scale from 0 to 200, with increments of 10. The graph displays the distribution of calcium levels within the group at each time interval.

Ossomark® 510(k) Submission Octor International, Inc.

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Image /page/7/Figure/0 description: The image is a bar graph comparing data at 1 month, 6 months, and 1 year. The y-axis ranges from -100 to 190. The data at 1 month is more spread out, ranging from -70 to 60. The data at 6 months and 1 year is more concentrated around 0.

cent Change from Basel

CALCIUM GROUP

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Baseline Osteomark® values and the percent change from baseline to 6 months are predictive of the change in BMD and/or response to HRT.

Figure 4 provides the baseline Osteomark® values and the percent change from baseline to six months stratified into quartiles, with the corresponding percent change in spine BMD after 1 year of HRT.

· Subjects in the highest quartile of Osteomark® values at baseline (67 188 nM BCE/mM creatinine), or with the greatest decrease from baseline to 6 months of therapy (-66 to -87%), showed the greatest gain in spine BMD in response to HRT.
AND $100k) St

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Image /page/9/Figure/0 description: Figure 4 shows the HRT Group values of baseline and percent change in Osteomark to six months stratified by quartile and corresponding percent change of L1-L4 BMD at 1 year. The figure provides information on the changes in bone mineral density (BMD) in the lumbar spine (L1-L4) over a one-year period. The data is stratified by quartile, which means the study population is divided into four groups based on their baseline Osteomark values.

Image /page/9/Figure/1 description: The image contains two bar charts that show the percent change in L1-L4 to one year. The top chart shows quartiles by osteomark at baseline, with Q1 (18-38) having a percent change of around 1.5, Q2 (38-51) having a percent change of around 2.4, Q3 (51-67) having a percent change of around 2.4, and Q4 (87-188) having a percent change of around 3.5. The bottom chart shows quartiles by percent change in osteomark to six months, with Q1 (192 to -22%) having a percent change of around 1.3, Q2 (-22 to -51%) having a percent change of around 0.8, Q3 (-51 to -66%) having a percent change of around 3.2, and Q4 (-66 to -87%) having a percent change of around 4.4.

Ortsomark® 510(k) Submission Outex International, Inc.

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Contingency table analysis showed that a >30% decrease at 6 months was significantly associated (p64 nM BCE/mM creatinine) had the greatest decrease in spine BMD.
Figure 6: Calcium Group - Average On-Study Osteomark® Values Stratified by Quartile and Corresponding Percent Change L1-L4 BMD at 1 Year

Image /page/12/Figure/3 description: The figure is a bar graph that shows the percent change in L1-L4 from baseline to one year. The x-axis shows the quartiles, Q1 (21-38), Q2 (38-49), Q3 (49-64), and Q4 (64-139). The y-axis shows the percent change L1-L4 from baseline to one year (+/- sem). The p-value for Q1 and Q2 is "ns", the p-value for Q3 is less than 0.02, the p-value for Q4 is less than 0.001, and the p-value between Q1 and Q4 is less than 0.005.

Quartiles of Average On-Study Osteomark (nM BCE/mM creatinine)

Ostoomark® 510(k) Submission Oran International, Inc.

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Table 1 compares the two treatment groups using Relative Risk analysis.

· A high baseline Osteomark® value (≥67 nM BCE/mM creatinine) indicated a 17.3 times higher risk of loss of spine BMD if not treated with HRT.
Table 1: Relative Risk of Loss of BMD Comparing Calcium and HRT Groups

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18-38	1.4	0.8 - 2.5
38-21	2.5	1.0 - 6.1
51-67	3.8	1.6 - 9.1
67-188	17.3	2.5 - 118.6

Use of Osteomark® to Monitor Estrogen Suppressing Therany

A multi-center, non-randomized, prospective, longitudinal clinical trial was conducted to determine the ability of the Osteomark® assay to monitor the effect of estrogen suppressing therapy on bone resorption in premenopausal women (Marshall et.al., 1996). Subjects were given GnRH-agonist therapy 3-6 months for treatment of varied gynecologic disorders.

The following data support the clinical utility of Osteomark® to monitor the effect of estrogen suppressing therapy.

Figure 7 represents the mean (± sem) Osteomark® values obtained throughout the study along with corresponding mean (± sem) estradiol values for each timepoint.

· The mean Osteomark® value at baseline was 44 ± 3 nM BCE/mM creatinine.
· The mean Osteomark® value while estrogen suppressed was 61 nM BCE/mM creatinine, a 68% increase from baseline.
· The mean serum estradiol level was 21 pg/mL during this time period.
· The Osteomark and estradiol values while estrogen suppressed were concordant with postmenopausal ranges of each analyte.

nicrnational. Inc

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Image /page/14/Figure/0 description: The image is a title for a figure. The title reads "Figure 7: Osteomark® Values and Serum Estradiol Levels (mean ± sem) During and After Estrogen Suppression Therapy". The title indicates that the figure will likely show data related to Osteomark values and serum estradiol levels. The data will be presented as mean ± sem, and will cover the period during and after estrogen suppression therapy.

Image /page/14/Figure/1 description: The image is a graph that shows the mean Osteomark and mean serum estradiol levels over time. The x-axis represents the time points: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 1 month post, and 3 months post. The y-axis on the left represents the mean Osteomark levels, while the y-axis on the right represents the mean serum estradiol levels. The Osteomark levels are represented by a bar graph, and the estradiol levels are represented by a line graph. The graph also indicates the period of estrogen suppression therapy.

Ostcomark® 510(k) Submission Ostex International, Inc.

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Figure 8 provides percent change in Osteomark® from baseline throughout the study for each subject.

· Sixty three percent (55/88) of the subjects had a mean percent change from baseline of≥30% (p=0.025).
· Subjects exhibiting 30% change (35 nM BCE/mM creatinine), accounting for the lesser percent change in Osteomark® in these individuals.
· The average on-therapy Osteomark value for the 30% group (66 nM BCE/mM creatinine). The 30% change group also tended to lose less bone at the spine than those who had a ≥ 30% change.

Oscomark® 510(k) Submission
Ostex International, Inc.

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Image /page/16/Figure/0 description: This image shows a graph of percent change from baseline during and after estrogen suppressing therapy. The x-axis represents different months, including month 1, mean of months 2 to 6, post 1 month, and post 3 months. The y-axis represents the percent change from baseline, ranging from -80 to 400. The graph shows the change in estrogen levels over time.

Figure 8: Osteomark® Percent Change from Baseline During and After Estrogen
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Further analysis showed:

· The mean 68% increase from baseline Osteomark® correlated to a mean percent decrease at six months of -3.7% in lumbar spine (L1-L4) BMD (r = - 0.46, p 40% decrease.
· After I year of therapy, the mean percent change from baseline Osteomark® remained similar to the values at 3 months (-65% ± 18); with 90% (77/86) ≤ 35 nM BCE/mM creatinine and 92% (77/84) of the subjects having a > 40% decrease,
· In the calcium only group, the Osteomark® values remained relatively constant, with a mean -13% ± 37 change (mean ± SD) from baseline at 1 year.

ark $10(k) Submission Ostex International, Inc.

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Table 6. Osteomark® Values (nM BCE/mM creatinine) in Osteoporotic Patients

Treated with Alendronate 10 mg plus Calcium Supplement or Calcium Supplements

Only (mean ± SD)

Treatment Group	Baseline	Month 1	Month 3	Month 6	Month 12	Month 24	Month 36
Alendronate 10mg and
Calcium*	$70 \pm 33$	$31 \pm 21$	$25 \pm 16$	$22 \pm 13$	$22 \pm 13$	$20 \pm 9$	$18 \pm 9$
Calcium only**	$69 \pm 33$	$57 \pm 28$	$58 \pm 26$	$54 \pm 26$	$54 \pm 25$	$52 \pm 21$	$56 \pm 20$

"N = 91, 88, 89, 88, 86, 80, and 78 respectively

*** = 188, 182, 183, 180,174, 157, and 149 respectively

Ostoomark® 510(k) Submission Ostex International, Inc.

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Figure 9 provides the percent change from baseline Osteomark® through 1 year of the study

Figure 9. Percent Change From Baseline Osteomark® Through 1 Year

romark® 510(k) Submission Ostex International, Inc.

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和米本原中出
ર	年世中中国中国政府在出台中山西	早晚上半年半年	年后半年半年出来中出
10	出申写出血中市角电	이 대	《母单单中半年日
13		本山市水田市市	.
20	**

                                                                                                                                                                     | oueb                                                                                                                                                                          |                                                                                                                                                                               |

| 25 | 年中中華車車車 | ***** | . 이 |
| 30 | | 내 내 | 사 등 방 파 등 |
| ਤੇ ਵ | ▲ 아 | | |
| 40 | � | 中中 | � |
| 4 3 | | | |
| રેપ | 바 | *** | 이 이 |
| ર ત | 年中班 | * | |
| 60 | | *** | ● 導 |
| રે ર | | � | * ● |
| 70 | | | |
| 7 ਵ | | | . . |
| 80 | | | . |
| દર | | | |
| 90 | | | 방 |
| ਹੈ ਕ | | 車車 | |
| 100 | | 中国 | |
| ા ૦ર | | | |
| 10 | ー | | |
| 113 | | | |
| 125
120 | | | |
| 130 | | | |
| 133 | | | |
| 140 | | | |
| I 42 | | | |
| 1 20 | | | |
| । ਵੇਡ | | | |
| 160 | | | |
| | | | |

crocal Change from Baselia

PLACEBO GROUP

25

Image /page/25/Figure/0 description: This figure shows the percent change from baseline for the Alendronate group at 1 month, 6 months, and 1 year. The y-axis shows the percent change from baseline, ranging from -100 to 160. At 1 month, the percent change from baseline ranges from -90 to 20, at 6 months, the percent change from baseline ranges from -95 to 10, and at 1 year, the percent change from baseline ranges from -90 to 15.

ALENDRONATE GROUP