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Completed

NCT Number: NCT00541658

A Study of a 35 mg Delayed Release Formulation of Risedronate for Osteoporosis

The purpose of this trial is to study the efficacy of a 35 mg delayed release weekly 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 35 mg delayed release given weekly and 5 mg immediate release given 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 or total hip BMD more that 2.5 SD below the young adult mean, or have lumbar spine or total hip 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 >32 kg/m
  • 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

5 mg Immediate-release Risedronate Administered At Least 30 Minutes Before Breakfast Daily

Other names: IRBB

Primary outcomes

  1. Percent Change From Baseline Lumbar Spine Bone Mineral Density (BMD) at Week 52 / Endpoint, ITT Population

    Time frame: 52 weeks / Endpoint

Secondary outcomes

  1. Percent Change From Baseline Lumbar Spine BMD for Combined 35 mg Delayed-Release Weekly Treatment Group, Week 52 / Endpoint, ITT Population

    Time frame: Week 52 / Endpoint

  2. Percent Change From Baseline Lumbar Spine BMD, Week 26, ITT Population

    Time frame: Week 26

  3. Percent Change From Baseline Lumbar Spine BMD, Week 52, ITT Population

    Time frame: Week 52

  4. Percent Change From Baseline Lumbar Spine BMD at Week 104, ITT Population

    Time frame: Week 104

  5. Percent Change From Baseline Lumbar Spine BMD at Week 104 / Endpoint, ITT Population

    Time frame: Week 104 / Endpoint

  6. Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD), Week 52, ITT Population

    Time frame: Week 52

    Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

  7. Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 52 / Endpoint, ITT Population

    Time frame: Week 52 / Endpoint

    Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

  8. Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104, ITT Population

    Time frame: Week 52

    Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

  9. Percent Responders to Treatment (>0% Change From Baseline in Lumbar Spine BMD) at Week 104 / Endpoint, ITT Population

    Time frame: Week 52 / Endpoint

    Responder = a patient showing a positive change (>0 g/cm2) in lumbar spine BMD from baseline to the timepoint.

  10. Percent Change From Baseline in Total Proximal Femur BMD, Week 26, ITT Population

    Time frame: Week 26

  11. Percent Change From Baseline in Total Proximal Femur BMD, Week 52, ITT Population

    Time frame: Week 52

  12. Percent Change From Baseline Total Proximal Femur BMD, Week 52 / Endpoint, ITT Population

    Time frame: Week 52 / Endpoint

  13. Percent Change From Baseline Total Proximal Femur BMD, Week 104, ITT Population

    Time frame: Week 104

  14. Percent Change From Baseline Total Proximal Femur BMD, Week 104 / Endpoint, ITT Population

    Time frame: Week 104 / Endpoint

  15. Percent Change From Baseline in Femoral Neck BMD, Week 26, ITT Population

    Time frame: Week 26

  16. Percent Change From Baseline in Femoral Neck BMD, Week 52, ITT Population

    Time frame: Week 52

  17. Percent Change From Baseline in Femoral Neck BMD, Week 52 / Endpoint, ITT Population

    Time frame: Week 52 / Endpoint

  18. Percent Change From Baseline in Femoral Neck BMD, Week 104, ITT Population

    Time frame: Week 104

  19. Percent Change From Baseline in Femoral Neck BMD, Week 104 / Endpoint, ITT Population

    Time frame: Week 104 / Endpoint

  20. Percent Change From Baseline Greater Trochanter BMD, Week 26, ITT Population

    Time frame: Week 26

  21. Percent Change From Baseline in Greater Trochanter BMD, Week 52, ITT Population

    Time frame: Week 52

  22. Percent Change From Baseline in Greater Trochanter BMD, Week 52 / Endpoint

    Time frame: Week 52 / Endpoint

  23. Percent Change From Baseline in Greater Trochanter BMD, Week 104, ITT Population

    Time frame: Week 104

  24. Percent Change From Baseline in Greater Trochanter BMD, Week 104 / Endpoint

    Time frame: Week 104 / Endpoint

  25. Percent Change From Baseline Urine Type-I Collagen N-telopeptide/ Creatinine (NTX/Cr), Week 13, ITT Population

    Time frame: Week 13

  26. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 26, ITT Population

    Time frame: Week 26

  27. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52, ITT Population

    Time frame: Week 52

  28. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 52 / Endpoint, ITT Population

    Time frame: Week 52 / Endpoint

  29. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104, ITT Population

    Time frame: Week 104

  30. Percent Change From Baseline Urine Type-I Collagen N-telopeptide / Creatinine (NTX / Cr), Week 104 / Endpoint, ITT Population

    Time frame: Week 104 / Endpoint

  31. Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 13, ITT Population

    Time frame: Week 13

  32. Percent Change From Baseline Serum Type-I Collagen C-telopeptide (CTX), Week 26, ITT Population

    Time frame: Week 26

  33. Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52, ITT Population

    Time frame: Week 52

  34. Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 52 / Endpoint, ITT Population

    Time frame: Week 52 / Endpoint

  35. Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104, ITT Population

    Time frame: Week 104

  36. Percent Change From Baseline in Serum Type-I Collagen C-telopeptide (CTX), Week 104 / Endpoint, ITT Population

    Time frame: Week 104 / Endpoint

  37. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 13, ITT Population

    Time frame: Week 13

  38. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 26, ITT Population

    Time frame: Week 26

  39. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52, ITT Population

    Time frame: Week 52

  40. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 52 / Endpoint, ITT Population

    Time frame: Week 52 / Endpoint

  41. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104, ITT Population

    Time frame: Week 104

  42. Percent Change From Baseline in Serum Bone-specific Alkaline Phosphatase, Week 104 / Endpoint, ITT Population

    Time frame: Week 104 / Endpoint

  43. Number of Patients With at Least One New Fractured Vertebra, Week 52

    Time frame: Week 52

  44. Number of Patients With at Least One New Fractured Vertebra, Week 52 / Endpoint, ITT Population

    Time frame: Week 52 / Endpoint

  45. Number of Patients With at Least One New Fractured Vertebra, Week 104, ITT Population

    Time frame: Week 104

  46. Number of Patients With at Least One New Fractured Vertebra, Week 104 / Endpoint, ITT Population

    Time frame: Week 104 / Endpoint

  47. Number of Patients With No New Fractured Vertebra, Week 52

    Time frame: Week 52

  48. Number of Patients With No New Fractured Vertebra, Week 52 / Endpoint

    Time frame: Week 52 / Endpoint

  49. Number of Patients With No New Fractured Vertebra, Week 104

    Time frame: Week 104

  50. Number of Patients With No New Fractured Vertebra, Week 104 / Endpoint

    Time frame: Week 104 / Endpoint

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Registry information

Official study title

A Non-inferiority Comparison of 35 mg Delayed-release Risedronate, Given Once-weekly Either Before or After Breakfast, & 5 mg Immediate-release Risedronate, Given Once-daily Before Breakfast, in the Treatment of Postmenopausal Osteoporosis.

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Oct 10, 2007
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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