Phase 3 Completed N=1,294 Randomized Double-blind Treatment

A Study of Monthly Risedronate for Osteoporosis

Postmenopausal Osteoporosis

Source: ClinicalTrials.gov NCT00247273 ↗

Enrolled (actual)

1,294

Serious AEs

9.9%

Results posted

Jun 2011

Primary outcomePrimary: Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population — 3.425; 3.540 Percent Change

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change From Baseline in Lumbar Spine Bone Mineral Density (BMD) at Month 12-Endpoint in Women With Postmenopausal Osteoporosis, Primary Efficacy Population	3.425; 3.540	—
SECONDARY Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population	3.522; 3.598	—
SECONDARY Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population	0.0256; 0.0261	—
SECONDARY Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)	3.927; 4.166	—
SECONDARY Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population	4.217; 4.302	—
SECONDARY Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population	0.0309; 0.0319	—
SECONDARY Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population	-30.04; -30.26	—
SECONDARY Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population	-51.83; -50.26	—
SECONDARY Change From Baseline in Urine NTX/Cr at Month 24, ITT Population	-28.88; -29.87	—
SECONDARY Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population	-49.45; -46.62	—
SECONDARY Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population	-0.36; -0.34	—
SECONDARY Percent Change From Baseline in Serum CTX at Month 6, ITT Population	-57.79; -53.62	—
SECONDARY Change From Baseline in Serum CTX at Month 24, ITT Population	-0.22; -0.20	—
SECONDARY Percent Change From Baseline in Serum CTX at Month 24, ITT Population	-29.33; -23.63	—
SECONDARY Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population	-5.31; -5.48	—
SECONDARY Percent Change From Baseline in Serum BAP at Month 6, ITT Population	-33.34; -34.66	—
SECONDARY Change From Baseline in Serum BAP at Month 24, ITT Population	-4.10; -4.22	—
SECONDARY Percent Change From Baseline in Serum BAP at Month 24, ITT Population	-25.84; -25.07	—
SECONDARY Number of Participants With New Vertebral Fracture at Month 12, ITT Population	8; 8	1.0000
SECONDARY Number of Participants With New Vertebral Fracture at Month 24, ITT Population	14; 14	1.0000

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00247273). 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. Informational only — not medical advice.