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

Warner Chilcott

Status and phase: Completed; Phase 2

Conditions: Postmenopausal

Treatments: Drug: experimental; Drug: risedronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00577837

2003134

HMR4003K/2001

Details and patient eligibility

About

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.

Enrollment: 370 patients

Sex: Female

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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370 participants in 4 patient groups

1

Active Comparator group

Description:

5 mg risedronate, once daily for 6 months

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate

2

Experimental group

Description:

100 mg risedronate, once a month for 6 months

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate

3

Experimental group

Description:

150 mg risedronate, once a month for 6 months

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate

4

Experimental group

Description:

200 mg risedronate, once a month for 6 months

Treatment:

Drug: experimental