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.
The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
1,294
tablet, 5 mg risedronate, once a day for 2 years
oral, 150 mg risedronate, once a month for 2 years
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).
Time frame: Baseline to Month 12 - Endpoint
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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Month 24
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Research Site
Lakewood, Colorado, United States
Research Site
Gainesville, Georgia, United States
Research Site
Bethesda, Maryland, United States
Research Site
Omaha, Nebraska, United States
Research Site
West Haverstraw, New York, United States
Research Site
Cincinnati, Ohio, United States
Research Site
Portland, Oregon, United States
Research Site
Buenos Aires, Buenos Aires, Argentina
Research Site
Capital Federal, Argentina
Research Site
Geelong, Australia
...and 39 more locations
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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline to Month 6
Percent Change From Baseline in Serum CTX at Month 6, ITT Population
Assayed by electrochemiluminescent immunoassay.
Time frame: Baseline to Month 6
Change From Baseline in Serum CTX at Month 24, ITT Population
Assayed by electrochemiluminescent immunoassay.
Time frame: Baseline to Month 24
Percent Change From Baseline in Serum CTX at Month 24, ITT Population
Assayed by electrochemiluminescent immunoassay.
Time frame: 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)
Time frame: Baseline to Month 6
Percent Change From Baseline in Serum BAP at Month 6, ITT Population
Assayed by ELISA (enzyme-linked immunosorbent assay)
Time frame: Baseline to Month 6
Change From Baseline in Serum BAP at Month 24, ITT Population
Assayed by ELISA (enzyme-linked immunosorbent assay)
Time frame: Baseline to Month 24
Percent Change From Baseline in Serum BAP at Month 24, ITT Population
Assayed by ELISA (enzyme-linked immunosorbent assay)
Time frame: Baseline to Month 24
Number of Participants With New Vertebral Fracture at Month 12, ITT Population
At least 1 new fractured vertebra
Time frame: Baseline to Month 12
Number of Participants With New Vertebral Fracture at Month 24, ITT Population
At least 1 new fractured vertebra
Time frame: Baseline to Month 24