Phase 3
N=285
Efficacy and Safety of Risedronate Therapy Administered 35 mg Once A Week in Men With Osteoporosis
Other Osteoporosis
Bottom Line
View on ClinicalTrials.gov: NCT00619957 ↗Enrolled (actual)
285
Serious AEs
14.5%
Results posted
Oct 2011
Primary outcome: Primary: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population. — 1.22; 5.75 Percent Change — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo tablet (Drug); Risedronate (Drug)
- Age
- Adult, Older Adult · 30+ yrs
- Sex
- Male
- Sponsor
- Warner Chilcott
- Primary completion
- May 2007
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD), 24 Months/Endpoint, ITT Population. |
1.22; 5.75 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lumbar Spine BMD, Month 6, ITT Population. |
1.03; 3.60 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lumbar Spine BMD, Month 12, ITT Population. |
1.42; 4.60 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Lumbar Spine BMD, Month 24, ITT Population. |
1.40; 5.98 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Proximal Femur BMD, Month 6, ITT Population. |
0.76; 1.16 | 0.1856 |
| SECONDARY Percent Change From Baseline in Total Proximal Femur BMD, Month 12, ITT Population. |
0.74; 1.38 | 0.0346 sig |
| SECONDARY Percent Change From Baseline in Total Proximal Femur BMD, Month 24, ITT Population. |
0.06; 1.76 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Total Proximal Femur BMD, 24 Months/Endpoint, ITT Population. |
0.24; 1.71 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Femoral Neck BMD, Month 6, ITT Population. |
0.48; 0.98 | 0.2538 |
| SECONDARY Percent Change From Baseline in Femoral Neck BMD, Month 12, ITT Population. |
0.62; 1.49 | 0.0537 |
| SECONDARY Percent Change From Baseline in Femoral Neck BMD, Month 24, ITT Population. |
0.42; 1.65 | 0.0081 sig |
| SECONDARY Percent Change From Baseline in Femoral Neck BMD, 24 Months/Endpoint, ITT Population. |
0.53; 1.59 | 0.0187 sig |
| SECONDARY Percent Change From Baseline in Femoral Trochanter BMD, Month 6, ITT Population. |
0.67; 1.24 | 0.1408 |
| SECONDARY Percent Change From Baseline in Femoral Trochanter BMD, Month 12, ITT Population. |
0.81; 1.89 | 0.0129 sig |
| SECONDARY Percent Change From Baseline in Femoral Trochanter BMD, Month 24, ITT Population. |
0.52; 2.83 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in Femoral Trochanter BMD, 24 Months/Endpoint, ITT Population. |
0.57; 2.73 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in CTx (Type I Collagen C-telopeptide), Month 3, ITT Population. |
-14.56; -58.16 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in CTx, Month 6, ITT Population. |
-13.72; -58.44 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in CTx, Month 12, ITT Population. |
-19.12; -61.46 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in CTx, Month 24, ITT Population. |
9.28; -37.27 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in CTx, 24 Months/Endpoint, ITT Population. |
6.39; -38.76 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in NTx/Cr (Type I Collagen N-telopeptide/Creatinine), Month 3, ITT Population. |
-17.41; -33.28 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in NTx/Cr, Month 6, ITT Population. |
-7.98; -29.97 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in NTx/Cr, Month 12, ITT Population. |
-16.46; -38.42 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in NTx/Cr, Month 24, ITT Population. |
-22.27; -37.38 | 0.0012 sig |
| SECONDARY Percent Change From Baseline in NTx/Cr, 24 Months/Endpoint, ITT Population. |
-20.45; -36.82 | 0.0003 sig |
| SECONDARY Percent Change From Baseline in BAP (Bone-specific Alkaline Phosphatase), Month 3, ITT Population. |
-8.89; -24.53 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in BAP, Month 6, ITT Population. |
-8.68; -29.78 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in BAP, Month 12, ITT Population. |
-7.11; -29.51 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in BAP, Month 24, ITT Population. |
2.95; -25.20 | <0.0001 sig |
| SECONDARY Percent Change From Baseline in BAP, 24 Months/Endpoint, ITT Population. |
1.99; -25.27 | <0.0001 sig |
| SECONDARY Change From Baseline in Body Height, Month 12, ITT Population. |
-0.77; -0.92 | 0.8794 |
| SECONDARY Change From Baseline in Body Height, Month 24, ITT Population. |
-2.66; -3.13 | 0.6658 |
| SECONDARY Change From Baseline in Body Height, 24 Months/Endpoint, ITT Population. |
-2.39; -2.68 | 0.7840 |
| SECONDARY Percent of Responders Lumbar Spine BMD, Month 24, ITT Population |
60.3; 89.5 | <0.0001 sig |
| SECONDARY Cumulative Incidence of Fractures, 12 Months, ITT Population |
3.4; 2.7 | 0.7284 |
| SECONDARY Cumulative Incidence of Fractures, 24 Months, ITT Population |
7.7; 4.9 | 0.5293 |
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.
Eligibility Criteria
Inclusion Criteria
- Documented osteoporosis of the femoral neck and lumbar spine
Exclusion Criteria
- BMI greater than or equal to 35
Data sourced from ClinicalTrials.gov (NCT00619957). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.