Pharmacokinetics of a Single 14C-labeled Dose of Risedronate or Alendronate Followed by Once-a-week Unlabeled Oral Dose

Warner Chilcott

Status and phase: Completed; Phase 1

Conditions: Osteoporosis; Osteopenia

Treatments: Drug: alendronate; Drug: risedronate

Study type: Interventional

Funder types: Industry

Identifiers

NCT00577850

2002095

Details and patient eligibility

About

The primary objective of this study is to compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.

Enrollment: 32 patients

Sex: Female

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• have medical history documentation verifying postmenopausal status of at least 2 years (natural or surgical). If not documented, confirmation will be required using estradiol < 20 pg/mL and follicle stimulating hormone (FSH) > 40 IU/mL;
• have osteopenia or osteoporosis (< 1.002 g/cm2 Lunar or < 0.882 g/cm2 Hologic) as determined by DXA of the lumbar spine (AP or PA view, L1-L4). This corresponds to a T-score of approximately < -1.5.

Exclusion criteria

• any clinically significant out-of-range laboratory values and vital signs,
• a clinically significant cardiovascular, hepatic, renal, or parathyroid disease, in the opinion of the Investigator
• a known hypersensitivity to bisphosphonates

Trial design

32 participants in 2 patient groups

1

Experimental group

Description:

0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks

Treatment:

Drug: risedronate

2

Active Comparator group

Description:

0.45 mg 14C-labeled alendronate, followed 7 days later with oral 70 mg of alendronate once a week for 52 weeks

Treatment:

Drug: alendronate