Assess the Safety, Efficacy, and Pharmacokinetics of Immediate and Delayed Release Weekly Risedronate

Warner Chilcott

Status and phase: Completed; Phase 2

Conditions: Postmenopausal Women

Treatments: Drug: risedronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00577720

2005107

Details and patient eligibility

About

To compare the efficacy 50 mg delayed-release risedronate tablet, dosed immediately after breakfast, to a 35 mg immediate-release tablet, administered according to labeling instructions.

Full description

To compare the efficacy, based on the bone turnover marker (BTM) serum Type I collagen C-telopeptide (CTx), of a 50 mg delayed-release risedronate tablet, administered immediately after a typical breakfast, to that of a 35 mg immediate-release tablet, administered according to labeling instructions (ie, at least 30 minutes prior to breakfast) in postmenopausal women after 13 weeks of treatment.

Enrollment: 181 patients

Sex: Female

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• In generally good health, as determined by medical history, physical examination, and laboratory test results
• Postmenopausal greater than 2 years, naturally or surgically based on medical history.

Exclusion criteria

• Used any of the following medications within 3 months prior to dosing or used any of the following medications for more than 1 month at any time within 6 months prior to dosing:

  • oral or parenteral glucocorticoids (5 mg prednisone or equivalent/day)
  • anabolic steroids
  • estrogens (oral, skin patch, or gel), except for low dose vaginal products or insertable estrogen ring, selective estrogen-receptor modulators, or estrogen-related drugs
  • progestins
  • calcitonin
  • vitamin D supplements
  • calcitriol, calcidiol, or alfacalcidol at any dose
  • any bisphosphonate
  • fluoride
  • strontium
  • parathyroid hormone, including teriparatide

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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181 participants in 4 patient groups

35 mg IRBB

Active Comparator group

Description:

35 mg immediate release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate

Drug: risedronate

35 mg DRFB

Experimental group

Description:

35 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate

Drug: risedronate

50 mg DRFB

Experimental group

Description:

50 mg delayed release risedronate tablet, immediately following breakfast, once a week for 13 weeks

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate

Drug: risedronate

50 mg DRBB

Experimental group

Description:

50 mg delayed release risedronate tablet, 30 minutes prior to breakfast, once a week for 13 weeks

Treatment:

Drug: risedronate

Drug: risedronate

Drug: risedronate

Drug: risedronate