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

NCT00577850 | Completed Phase 1

• 1 other identifier: 2002095
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Osteopenia; Osteoporosis

Outcome Measures

Primary Outcomes (1)

• compare the urinary excretion of 14C-labeled risedronate and alendronate over 28 days.

  28 days

Secondary Outcomes (1)

• to compare urinary excretion and serum concentration-time profiles of 14C-labeled risedronate and alendronate over 52 weeks.

  52 weeks

Study Arms (2)

1

EXPERIMENTAL

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

Drug: risedronate

2

ACTIVE COMPARATOR

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

Drug: alendronate

Interventions

risedronate DRUG

0.23 mg 14C-labeled risedronate, followed 7 days later with oral 35 mg risedronate once a week for 52 weeks followed by another 14C-labeled risedronate followed weekly by 35 mg risedronate for 3 weeks

1

alendronate DRUG

0.45 mg 14C-labeled alendronate, followed 7 days later with oral 705 mg alendronate once a week for 52 weeks followed by another 14C-labeled alendronate followed weekly by 70 mg alendronate for 3 weeks

2

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Warner Chilcott: lead
• Sanofi: collaborator

Study Sites (2)

Research Facility

Gainesville, Florida, United States

Location

Research Site

New Orleans, Louisiana, United States

Location

MeSH Terms

Conditions

Bone Diseases, Metabolic; Osteoporosis

Interventions

Risedronic Acid; Alendronate

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Diphosphonates; Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Amy Sun, MD, PhD

  Procter and Gamble

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 19, 2007
• First Posted: December 20, 2007
• Study Start: November 1, 2002
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: April 17, 2013

Record last verified: 2013-04

Locations

US (2)