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

Phase 3

Completed

• Conditions: Other Osteoporosis
• Interventions: Drug: Placebo tablet; Drug: Risedronate

• Registration Number: NCT00619957
• Lead Sponsor: Warner Chilcott

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-06
• Primary Completion: 2007-05
• Study Completion: 2007-05
• Study First Submitted: 2008-02-11
• Study First Submitted QC: 2008-02-11
• Study First Posted: 2008-02-21
• Results First Submitted: 2011-05-23
• Status Verified: 2011-09
• Results First Submitted QC: 2011-09-20
• Last Update Submitted: 2011-09-20
• Results First Posted: 2011-10-28
• Last Update Posted: 2011-10-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 285

Inclusion Criteria

• Documented osteoporosis of the femoral neck and lumbar spine

Exclusion Criteria

• BMI greater than or equal to 35

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Placebo tablet	Placebo tablet once a week for 2 years followed by once a week Risedronate for 2 years
Risedronate	Risedronate	35 mg risedronate tablet once a week for 2 years followed by open label 35 mg risedronate once a week for 2 years

Primary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population.	Baseline to 24 Months/Endpoint	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).

Secondary Outcome Measures

Name	Time	Method
Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population.	Baseline to Month 12	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).
Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population.	Baseline to Month 6	DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population.	Baseline to Month 12	DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population.	Baseline to Month 24	DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population.	Baseline to 24 Months/Endpoint	DXA (dual energy x-ray absorptiometry) assayed on Lunar or Hologic machines. Scans will be forwarded to central facility for analysis.
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	Baseline to Month 24	responder = positive change (\>0) in lumbar spine BMD from Baseline to Month 24
Cumulative Incidence of Fractures, 12 Months, ITT Population	Baseline to Month 12	Kaplan-Meier Cumulative Incidence, fractures / 100 patients / year
Cumulative Incidence of Fractures, 24 Months, ITT Population	Baseline to Month 24	Kaplan-Meier Cumulative Incidence, fractures / 100 patients / 2 years
Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population.	Baseline to Month 6	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).
Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population.	Baseline to Month 24	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).
Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population.	Baseline to Month 24	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).
Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population.	Baseline to Month 6	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).
Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population.	Baseline to Month 12	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).
Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population.	Baseline to 24 Months/Endpoint	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).
Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population.	Baseline to Month 6	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
Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population.	Baseline to Month 12	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
Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population.	Baseline to Month 24	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
Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population.	Baseline to 24 Months/Endpoint	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

Trial Locations

Locations (2)

Research Facility; 🇭🇺 Budapest, Hungary

Research Site; 🇬🇧 Sheffield, United Kingdom