Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis

Study Overview
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Brief Summary
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Two year study to determine the safety and efficacy of weekly 35 mg Risedronate doses in men with osteoporosis followed by a two year follow-up study.

Official Title
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Two-year Study to Determine the Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis for 2 Years Followed by a 2 Year Open Label Study

Conditions
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Other Osteoporosis

Intervention / Treatment
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* Drug: Placebo tablet
* Drug: Risedronate


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Documented osteoporosis of the femoral neck and lumbar spine Exclusion Criteria: BMI greater than or equal to 35

Ages Eligible for Study
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Minimum Age: 30 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years | Drug: Placebo tablet<br>* one placebo once a week for two years followed by one 35 mg risedronate once a week for two years<br>|
| Experimental: Risedronate<br>35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years | Drug: Risedronate<br>* one 35 mg risedronate once a week for two years followed by one 35 mg risedronate once a week for two years<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Site will perform at screening to determine if scan should be forwarded to central facility for analysis. Mean of 2 scans performed read by central lab to determine entry qualification. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). | Baseline to 24 Months/Endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading.DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). | Baseline to Month 6 | 
| Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). | Baseline to Month 12 | 
| Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Mean of 2 scans performed. Results standardized (sBMD): Hologic sBMD = 1000 x (BMD x 1.0755), Lunar sBMD = 1000 x (BMD x 0.9522). | Baseline to Month 24 | 
| Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). | Baseline to Month 6 | 
| Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines and forwarded to central laboratory for reading. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). | Baseline to Month 12 | 
| Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). | Baseline to Month 24 | 
| Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Results standardized (sBMD): Hologic sBMD = 1000 x (1.008 x BMD + 0.006), Lunar sBMD = 1000 x (0.979 x BMD - 0.031). | Baseline to 24 Months/Endpoint | 
| Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic Reference BMD = (0.836 x BMD[lunar]) - 0.008 | Baseline to Month 6 | 
| Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008 | Baseline to Month 12 | 
| Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008 | Baseline to Month 24 | 
| Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. Mean of 2 scans performed will be utilized. Baseline femoral neck values measured on Lunar instruments will be normalized to Hologic reference. Hologic reference BMD = (0.836 x BMD[lunar]) - 0.008 | Baseline to 24 Months/Endpoint | 
| Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. | Baseline to Month 6 | 
| Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. | Baseline to Month 12 | 
| Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. | Baseline to Month 24 | 
| Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population. | DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis. | Baseline to 24 Months/Endpoint | 
| Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population. |  | Baseline to Month 3 | 
| Percent Change From Baseline in CTx, Month 6, ITT Population. |  | Baseline to Month 6 | 
| Percent Change From Baseline in CTx, Month 12, ITT Population. |  | Baseline to Month 12 | 
| Percent Change From Baseline in CTx, Month 24, ITT Population. |  | Baseline to Month 24 | 
| Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population. |  | Baseline to 24 Months/Endpoint | 
| Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population. |  | Baseline to Month 3 | 
| Percent Change From Baseline in NTx/Cr, Month 6, ITT Population. |  | Baseline to Month 6 | 
| Percent Change From Baseline in NTx/Cr, Month 12, ITT Population. |  | Baseline to Month 12 | 
| Percent Change From Baseline in NTx/Cr, Month 24, ITT Population. |  | Baseline to Month 24 | 
| Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population. |  | Baseline to 24 Months/Endpoint | 
| Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population. |  | Baseline to Month 3 | 
| Percent Change From Baseline in BAP, Month 6, ITT Population. |  | Baseline to Month 6 | 
| Percent Change From Baseline in BAP, Month 12, ITT Population. |  | Baseline to Month 12 | 
| Percent Change From Baseline in BAP, Month 24, ITT Population. |  | Baseline to Month 24 | 
| Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population. |  | Baseline to 24 Months/Endpoint | 
| Change From Baseline in Body Height, Month 12, ITT Population. |  | Baseline to Month 12 | 
| Change From Baseline in Body Height, Month 24, ITT Population. |  | Baseline to Month 24 | 
| Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population. |  | Baseline to 24 Months/Endpoint | 
| Percent of Responders Lumbar Spine BMD, Month 24, ITT Population | responder = positive change (>0) in lumbar spine BMD from Baseline to Month 24 | Baseline to Month 24 | 
| Cumulative Incidence of Fractures, 12 Months, ITT Population | Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year | Baseline to Month 12 | 
| Cumulative Incidence of Fractures, 24 Months, ITT Population | Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years | Baseline to Month 24 |