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OpenTrials
Completed

NCT Number: NCT00247273

A Study of Monthly Risedronate for Osteoporosis

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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Age range

50 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Buenos Aires, Argentina

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

risedronate

Drug

tablet, 5 mg risedronate, once a day for 2 years

Primary outcomes

  1. 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

    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 outcomes

  1. Percent Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population

    Time frame: Baseline to Month 12

    BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

  2. Change From Baseline in Lumbar Spine BMD at Month 12, ITT Population

    Time frame: Baseline to Month 12

    BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

  3. Percent Change From Baseline in Lumbar Spine BMD at Month 24-Endpoint, Endpoint Population (Month 24)

    Time frame: 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).

  4. Percent Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population

    Time frame: Baseline to Month 24

    BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

  5. Change From Baseline in Lumbar Spine BMD at Month 24, ITT Population

    Time frame: Baseline to Month 24

    BMD assessed using dual-energy x-ray absorptiometry (DXA) using Hologic or Lunar equipment.

  6. 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

    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

  7. Percent Change From Baseline in Urine NTX/Cr at Month 6, ITT Population

    Time frame: 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.

  8. Change From Baseline in Urine NTX/Cr at Month 24, ITT Population

    Time frame: 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.

  9. Percent Change From Baseline in Urine NTX/Cr at Month 24, ITT Population

    Time frame: 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.

  10. Change From Baseline in Serum Type-1 Collagen Cross-linked C-telopeptide (CTX) at Month 6, ITT Population

    Time frame: Baseline to Month 6

    ng / mL = nanograms / milliliter. Assayed by electrochemiluminescent immunoassay.

  11. Percent Change From Baseline in Serum CTX at Month 6, ITT Population

    Time frame: Baseline to Month 6

    Assayed by electrochemiluminescent immunoassay.

  12. Change From Baseline in Serum CTX at Month 24, ITT Population

    Time frame: Baseline to Month 24

    Assayed by electrochemiluminescent immunoassay.

  13. Percent Change From Baseline in Serum CTX at Month 24, ITT Population

    Time frame: Baseline to Month 24

    Assayed by electrochemiluminescent immunoassay.

  14. Change From Baseline in Serum Bone-specific Alkaline Phosphatase (BAP) at Month 6, ITT Population

    Time frame: Baseline to Month 6

    ug / L = micrograms per liter, Assayed by ELISA (enzyme-linked immunosorbent assay)

  15. Percent Change From Baseline in Serum BAP at Month 6, ITT Population

    Time frame: Baseline to Month 6

    Assayed by ELISA (enzyme-linked immunosorbent assay)

  16. Change From Baseline in Serum BAP at Month 24, ITT Population

    Time frame: Baseline to Month 24

    Assayed by ELISA (enzyme-linked immunosorbent assay)

  17. Percent Change From Baseline in Serum BAP at Month 24, ITT Population

    Time frame: Baseline to Month 24

    Assayed by ELISA (enzyme-linked immunosorbent assay)

  18. Number of Participants With New Vertebral Fracture at Month 12, ITT Population

    Time frame: Baseline to Month 12

    At least 1 new fractured vertebra

  19. Number of Participants With New Vertebral Fracture at Month 24, ITT Population

    Time frame: Baseline to Month 24

    At least 1 new fractured vertebra

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Collaborators

  • Sanofi

Registry information

Official study 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)

Important dates

Study start
2005
Primary completion
2008
Study completion
2008
First posted
Nov 1, 2005
Registry last updated
Apr 22, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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