A Study of Monthly Risedronate for Osteoporosis

Official Title: “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)”

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.

Intervention(s) in this Clinical Trial

• Drug: risedronate
  • tablet, 5 mg risedronate, once a day for 2 years
• Drug: risedronate
  • oral, 150 mg risedronate, once a month for 2 years

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: 1
  • 5 mg risedronate, once daily for 2 years
• Experimental: 2
  • 150 mg risedronate taken once a month for 2 years

Primary Measures

• 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
    Safety Issue?: No

Secondary Measures

• Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
  • Time Frame: Baseline to Month 12
    Safety Issue?: No
• Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population
  • Time Frame: Baseline to Month 12
    Safety Issue?: No
• Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)
  • Time Frame: Baseline to Month 24 - Endpoint
    Safety Issue?: No
• Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
  • Time Frame: Baseline to Month 24
    Safety Issue?: No
• Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population
  • Time Frame: Baseline to Month 24
    Safety Issue?: No
• Change From Baseline in Urine Type-1 Collagen Cross-linked-N-telopeptide Corrected for Creatinine Clearance (NTX/Cr) at Month 6, ITT Population
  • Time Frame: Baseline to Month 6
    Safety Issue?: No
• Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population
  • Time Frame: Baseline to Month 6
    Safety Issue?: No
• Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
  • Time Frame: Baseline to Month 24
    Safety Issue?: No
• Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population
  • Time Frame: Baseline to Month 24
    Safety Issue?: No
• Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population
  • Time Frame: Baseline to Month 6
    Safety Issue?: No
• Percent Change From Baseline in Serum CTX at Month 6, ITT Population
  • Time Frame: Baseline to Month 6
    Safety Issue?: No
• Change From Baseline in Serum CTX at Month 24, ITT Population
  • Time Frame: Baseline to Month 24
    Safety Issue?: No
• Percent Change From Baseline in Serum CTX at Month 24, ITT Population
  • Time Frame: Baseline to Month 24
    Safety Issue?: No
• Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population
  • Time Frame: Baseline to Month 6
    Safety Issue?: No
• Percent Change From Baseline in Serum BAP at Month 6, ITT Population
  • Time Frame: Baseline to Month 6
    Safety Issue?: No
• Change From Baseline in Serum BAP at Month 24, ITT Population
  • Time Frame: Baseline to Month 24
    Safety Issue?: No
• Percent Change From Baseline in Serum BAP at Month 24, ITT Population
  • Time Frame: Baseline to Month 24
    Safety Issue?: No
• Number of Participants With New Vertebral Fracture at Month 12, ITT Population
  • Time Frame: Baseline to Month 12
    Safety Issue?: No
• Number of Participants With New Vertebral Fracture at Month 24, ITT Population
  • Time Frame: Baseline to Month 24
    Safety Issue?: 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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 50 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: Warner Chilcott Industry

Overall Clinical Trial Officials and Contacts

Sal Bartelmo, MD Study Director P&G  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00247273

Study ID Number: 2005032

ClinicalTrials.gov Identifier: NCT00247273

Health Authority: United States: Food and Drug Administration