NCT00247273CompletedPhase 3
A Phase III, Multicenter, Double-blind, Randomized, Active-controlled, Parallel Group, Non-inferiority Study Comparing 150 mg Risedronate Monthly With 5 mg Risedronate Daily in the Treatment of Postmenopausal Osteoporosis (PMO)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Warner Chilcott
- Enrollment
- 1,294
- Locations
- 1
- Primary Endpoint
- Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
Study Overview
Brief Summary
The purpose of this trial is to study the efficacy of a single-dose monthly dosing regimen as compared to the standard daily dosing regimen of risedronate 5 mg daily.
Detailed Description
The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 50 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Female: 50 years of age or older
- •>5 years since last menses natural or surgical
- •have lumbar spine BMD (bone mineral density) more that 2.5 standard deviations (SD) below the young adult mean, or have 1-spine BMD more than 2.0 SD below the young adult female mean value and also have at least one prevalent vertebral body fracture
Exclusion Criteria
- •history of uncontrolled hyperparathyroidism, hyperthyroidism, osteomalacia
- •BMI (body mass index) >32 kg/m^2
- •use of medications within 3 months of starting study drug that impact bone metabolism such as glucocorticoids, estrogens, calcitonin, calcitriol, other bisphosphonates and parathyroid hormone
- •hypocalcemia or hypercalcemia of any cause
- •markedly abnormal clinical laboratory measurements that are assessed as clinically significant by the investigator
Arms & Interventions
1
Active Comparator
5 mg risedronate, once daily for 2 years
Intervention: risedronate (Drug)
2
Experimental
150 mg risedronate taken once a month for 2 years
Intervention: risedronate (Drug)
Outcomes
Primary Outcomes
Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population
Time Frame: Baseline to Month 12 - Endpoint
BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. LOCF - last observation carried forward (Last post-baseline measurement available to Month 12).
Secondary Outcomes
- Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population(Baseline to Month 24)
- Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population(Baseline to Month 6)
- Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population(Baseline to Month 6)
- Change From Baseline in Urine NTX/Cr at Month 24, ITT Population(Baseline to Month 24)
- Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population(Baseline to Month 6)
- Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)(Baseline to Month 24 - Endpoint)
- Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population(Baseline to Month 24)
- Percent Change From Baseline in Serum CTX at Month 6, ITT Population(Baseline to Month 6)
- Percent Change From Baseline in Serum BAP at Month 24, ITT Population(Baseline to Month 24)
- Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population(Baseline to Month 12)
- Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population(Baseline to Month 12)
- Change From Baseline in Serum CTX at Month 24, ITT Population(Baseline to Month 24)
- Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population(Baseline to Month 6)
- Change From Baseline in Serum BAP at Month 24, ITT Population(Baseline to Month 24)
- Number of Participants With New Vertebral Fracture at Month 12, ITT Population(Baseline to Month 12)
- Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population(Baseline to Month 24)
- Percent Change From Baseline in Serum BAP at Month 6, ITT Population(Baseline to Month 6)
- Percent Change From Baseline in Serum CTX at Month 24, ITT Population(Baseline to Month 24)
- Number of Participants With New Vertebral Fracture at Month 24, ITT Population(Baseline to Month 24)
Investigators
Study Sites (1)
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