A Study of Monthly Risedronate for Osteoporosis
- Registration Number
- NCT00247273
- Lead Sponsor
- Warner Chilcott
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 1294
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2 risedronate 150 mg risedronate taken once a month for 2 years 1 risedronate 5 mg risedronate, once daily for 2 years
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population 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 Outcome Measures
Name Time Method Percent Change From Baseline in Serum CTX at Month 24, ITT Population Baseline to Month 24 Assayed by electrochemiluminescent immunoassay.
Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population Baseline to Month 24 BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
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 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
Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population Baseline to Month 6 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.
Change From Baseline in Urine NTX/Cr at Month 24, ITT Population Baseline to Month 24 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.
Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population Baseline to Month 6 ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.
Number of Participants With New Vertebral Fracture at Month 12, ITT Population Baseline to Month 12 At least 1 new fractured vertebra
Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24) Baseline to Month 24 - 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 24).
Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population Baseline to Month 24 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.
Percent Change From Baseline in Serum CTX at Month 6, ITT Population Baseline to Month 6 Assayed by electrochemiluminescent immunoassay.
Percent Change From Baseline in Serum BAP at Month 24, ITT Population Baseline to Month 24 Assayed by ELISA (enzyme-linked immunosorbent assay)
Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population Baseline to Month 12 BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population Baseline to Month 12 BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Change From Baseline in Serum CTX at Month 24, ITT Population Baseline to Month 24 Assayed by electrochemiluminescent immunoassay.
Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population Baseline to Month 6 ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)
Change From Baseline in Serum BAP at Month 24, ITT Population Baseline to Month 24 Assayed by ELISA (enzyme-linked immunosorbent assay)
Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population Baseline to Month 24 BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.
Percent Change From Baseline in Serum BAP at Month 6, ITT Population Baseline to Month 6 Assayed by ELISA (enzyme-linked immunosorbent assay)
Number of Participants With New Vertebral Fracture at Month 24, ITT Population Baseline to Month 24 At least 1 new fractured vertebra
Trial Locations
- Locations (1)
Research Site
🇪🇸Madrid, Spain