A Study of Monthly Risedronate for Osteoporosis

Study Overview
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Brief Summary
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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
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The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

Official Title
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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
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Postmenopausal Osteoporosis

Intervention / Treatment
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* Drug: risedronate
* Drug: risedronate


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

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 |
| --- | --- |
| Active Comparator: 1<br>5 mg risedronate, once daily for 2 years | Drug: risedronate<br>* tablet, 5 mg risedronate, once a day for 2 years<br>Drug: risedronate<br>* oral, 150 mg risedronate, once a month for 2 years<br>|
| Experimental: 2<br>150 mg risedronate taken once a month for 2 years | Drug: risedronate<br>* oral, 150 mg risedronate, once a month for 2 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) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population | 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). | Baseline to Month 12 - Endpoint | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. | Baseline to Month 12 | 
| Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. | Baseline to Month 12 | 
| Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24) | 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 24). | Baseline to Month 24 - Endpoint | 
| Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. | Baseline to Month 24 | 
| Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population | BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment. | 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 | Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. nmol BCE / mmol Creatinine = nanomoles bone collagen equivalents / millimoles Creatinine | Baseline to Month 6 | 
| Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population | Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. | Baseline to Month 6 | 
| Change From Baseline in Urine NTX/Cr at Month 24, ITT Population | Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. | Baseline to Month 24 | 
| Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population | Assayed by ELISA (enzyme-linked immunosorbent assay) for NTX and colorimetric assay for creatinine. Patient collected second urine voided between 6 and 9 am from day of clinic visit and day before clinic visit at Months 3, 6, 12 & 24. | Baseline to Month 24 | 
| Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population | ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay. | Baseline to Month 6 | 
| Percent Change From Baseline in Serum CTX at Month 6, ITT Population | Assayed by electrochemiluminescent immunoassay. | Baseline to Month 6 | 
| Change From Baseline in Serum CTX at Month 24, ITT Population | Assayed by electrochemiluminescent immunoassay. | Baseline to Month 24 | 
| Percent Change From Baseline in Serum CTX at Month 24, ITT Population | Assayed by electrochemiluminescent immunoassay. | Baseline to Month 24 | 
| Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population | ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay) | Baseline to Month 6 | 
| Percent Change From Baseline in Serum BAP at Month 6, ITT Population | Assayed by ELISA (enzyme-linked immunosorbent assay) | Baseline to Month 6 | 
| Change From Baseline in Serum BAP at Month 24, ITT Population | Assayed by ELISA (enzyme-linked immunosorbent assay) | Baseline to Month 24 | 
| Percent Change From Baseline in Serum BAP at Month 24, ITT Population | Assayed by ELISA (enzyme-linked immunosorbent assay) | Baseline to Month 24 | 
| Number of Participants With New Vertebral Fracture at Month 12, ITT Population | At least 1 new fractured vertebra | Baseline to Month 12 | 
| Number of Participants With New Vertebral Fracture at Month 24, ITT Population | At least 1 new fractured vertebra | Baseline to Month 24 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized controlled trial, osteoporosis, risedronate