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OpenTrials
Completed

NCT Number: NCT00577837

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

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.

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Key information

Conditions

Postmenopausal

Age range

50 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Hamilton, Ontario, Canada

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

risedronate

Drug

tablet, 5 mg risedronate daily for 6 months

Experimental

Drug

tablet, 200 mg risedronate monthly for 6 months

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Collaborators

  • Sanofi

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2005
Study completion
2005
First posted
Dec 20, 2007
Registry last updated
Apr 17, 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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