A Study of Monthly Risedronate for Osteoporosis

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00247273
First received: October 28, 2005
Last updated: April 15, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Postmenopausal Osteoporosis
Drug: risedronate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Warner Chilcott:

Primary Outcome 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 ] [ Designated as safety issue: No ]
    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:
  • Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

  • Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24) [ Time Frame: Baseline to Month 24 - Endpoint ] [ Designated as safety issue: No ]
    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 Lumbar Spine BMD at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

  • Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    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 Urine NTX/Cr at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.

  • Percent Change From Baseline in Serum CTX at Month 6, ITT Population [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Assayed by electrochemiluminescent immunoassay.

  • Change From Baseline in Serum CTX at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Assayed by electrochemiluminescent immunoassay.

  • Percent Change From Baseline in Serum CTX at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Assayed by electrochemiluminescent immunoassay.

  • Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)

  • Percent Change From Baseline in Serum BAP at Month 6, ITT Population [ Time Frame: Baseline to Month 6 ] [ Designated as safety issue: No ]
    Assayed by ELISA (enzyme-linked immunosorbent assay)

  • Change From Baseline in Serum BAP at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Assayed by ELISA (enzyme-linked immunosorbent assay)

  • Percent Change From Baseline in Serum BAP at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    Assayed by ELISA (enzyme-linked immunosorbent assay)

  • Number of Participants With New Vertebral Fracture at Month 12, ITT Population [ Time Frame: Baseline to Month 12 ] [ Designated as safety issue: No ]
    At least 1 new fractured vertebra

  • Number of Participants With New Vertebral Fracture at Month 24, ITT Population [ Time Frame: Baseline to Month 24 ] [ Designated as safety issue: No ]
    At least 1 new fractured vertebra


Enrollment: 1294
Study Start Date: October 2005
Study Completion Date: April 2008
Primary Completion Date: March 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
5 mg risedronate, once daily for 2 years
Drug: risedronate
tablet, 5 mg risedronate, once a day for 2 years
Drug: risedronate
oral, 150 mg risedronate, once a month for 2 years
Experimental: 2
150 mg risedronate taken once a month for 2 years
Drug: risedronate
oral, 150 mg risedronate, once a month for 2 years

Detailed Description:

The comparator arms of this risedronate study are 150 mg monthly and 5 mg daily.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00247273

  Show 49 Study Locations
Sponsors and Collaborators
Warner Chilcott
Sanofi
Investigators
Study Director: Sal Bartelmo, MD P&G
  More Information

No publications provided

Responsible Party: Warner Chilcott
ClinicalTrials.gov Identifier: NCT00247273     History of Changes
Other Study ID Numbers: 2005032, EFC6062 AND HMRF004M/3001
Study First Received: October 28, 2005
Results First Received: March 4, 2011
Last Updated: April 15, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Warner Chilcott:
randomized controlled trial, osteoporosis, risedronate

Additional relevant MeSH terms:
Osteoporosis
Osteoporosis, Postmenopausal
Bone Diseases, Metabolic
Bone Diseases
Musculoskeletal Diseases
Risedronic acid
Etidronic Acid
Calcium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses
Bone Density Conservation Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 30, 2014