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

Phase 2

Completed

• Conditions: Postmenopausal
• Interventions: Drug: experimental; Drug: risedronate

• Registration Number: NCT00577837
• Lead Sponsor: Warner Chilcott

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-04
• Primary Completion: 2005-06
• Study Completion: 2005-06
• Study First Submitted: 2007-12-19
• Study First Submitted QC: 2007-12-19
• Study First Posted: 2007-12-20
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-15
• Last Update Posted: 2013-04-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 370

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
4	experimental	200 mg risedronate, once a month for 6 months
2	risedronate	100 mg risedronate, once a month for 6 months
1	risedronate	5 mg risedronate, once daily for 6 months
3	risedronate	150 mg risedronate, once a month for 6 months

Primary Outcome Measures

Name	Time	Method
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	6 months

Secondary Outcome Measures

Name	Time	Method
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	6 months

Trial Locations

Locations (2)

Research Facility; 🇵🇱 Bialystok, Poland

Research Site; 🇵🇱 Wroclaw, Poland