Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
Warner Chilcott
ClinicalTrials.gov Identifier:
NCT00577837
First received: December 19, 2007
Last updated: April 15, 2013
Last verified: April 2013

December 19, 2007
April 15, 2013
April 2004
June 2005   (final data collection date for primary outcome measure)
Evaluate the safety of 3 once-monthly dosing regimens of risedronate, 100 mg, 150 mg and 200 mg, compared to a once-daily dosing regimen, 5 mg, as assessed by clinical laboratory values and adverse event (AE) profiles [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00577837 on ClinicalTrials.gov Archive Site
Evaluate the efficacy of 3 once-monthly dosing regimens or risedronate compared to a once-daily dosing regimen and to evaluate the PK/PD of monthly and daily dose regimens [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety, Pharmacokinetics, and Efficacy of 100, 150, and 200 mg Risedronate Administered to Women With Low BMD
Active-controlled, Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly in Postmenopausal Women With Low Bone Mineral Density

A Multi-center, Active-controlled (5 mg daily risedronate), Double-blind, Randomized, Sequential Escalating Dose Study to Assess Safety, Pharmacokinetics and Efficacy of 100, 150, and 200 mg Oral Risedronate Administered Monthly for Six Months in Postmenopausal Women with Low Bone Mineral Density.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Postmenopausal
  • Drug: risedronate
    tablet, 5 mg risedronate daily for 6 months
  • Drug: risedronate
    tablet, 100 mg risedronate monthly for 6 months
  • Drug: risedronate
    tablet, 150 mg risedronate monthly for 6 months
  • Drug: experimental
    tablet, 200 mg risedronate monthly for 6 months
  • Active Comparator: 1
    5 mg risedronate, once daily for 6 months
    Intervention: Drug: risedronate
  • Experimental: 2
    100 mg risedronate, once a month for 6 months
    Intervention: Drug: risedronate
  • Experimental: 3
    150 mg risedronate, once a month for 6 months
    Intervention: Drug: risedronate
  • Experimental: 4
    200 mg risedronate, once a month for 6 months
    Intervention: Drug: experimental
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
370
June 2005
June 2005   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • be postmenopausal 5 years based on medical history; follicle stimulating hormone and estradiol will be evaluated for any patient less than 65 years of age, who has undergone hysterectomy without bilateral oophorectomy, to ensure the patient is postmenopausal

Exclusion Criteria:

  • use of any of the following medications within 3 months of starting study drug or use of any of the following medications for more than 1 month at any time within 6 months prior to starting study drug:

    • oral or parenteral glucocorticoids (5 mg prednisone or equivalent per day)
    • anabolic steroids
    • estrogen, raloxifene or estrogen-related drugs, eg, tamoxifen, tibolone, (except for low dose vaginal creams, tablets or insertable estrogen ring
    • progestogen
    • calcitonin
    • vitamin D supplements (greater than 800 IU per day)
    • calcitriol, calcidiol, or alfacalcidol
    • any bisphosphonate
    • fluoride (10 mg per day)
    • strontium and other bone active agents
    • parathyroid hormone
    • heparin, warfarin, and other similar anticoagulants
Female
50 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Croatia,   Netherlands,   Poland
 
NCT00577837
2003134, HMR4003K/2001
No
Warner Chilcott
Warner Chilcott
Sanofi
Study Director: John Beary, MD Procter and Gamble
Warner Chilcott
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP