Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Alendronate or Risedronate

Warner Chilcott

Status: Completed

Conditions: Postmenopausal Osteoporosis

Study type: Observational

Funder types: Industry

Identifiers

NCT00778154

2003096

Details and patient eligibility

About

Patients who have received the appropriate number of years of alendronate or risedronate therapy will be recruited. Each patient will have received baseline BMD measurements performed at the spine and the hip by DXA. Each patient will receive tetracycline to label the bone and then have a transiliac bone biopsy. One year later teh bone label and biopsy procedure will be repeated.

Enrollment: 105 patients

Sex: Female

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women at least 5 years postmenopausal
• Subjects treated with any combination alendronate 10 mg daily or 70 mg once weekly or any combination of risedronate 5mg daily or 35 mg weekly for 3-5 years. Or subjects treated with any combination of alendronate 10 mg daily or 70 mg once weekly or any combination of risedronate 5mg daily or 35 mg weekly for greater than 5 years.

Exclusion criteria

• Presence of metabolic bone disease other than PMO
• Use of any medication other than alendronate or risedronate within with in the past 6 months likely to interfere with skeletal homeostasis.

Uncontrolled hyperthyroidism. Previous history of malignancy except treated squamous cell or basal cell carcinoma of the skin.

• Alcohol or drug abuse, current or within the past 5 years.
• Allergy to tetracycline, Novocain, or Versed.
• Hip anatomy not conducive to transiliac bone biopsy or DXA scan.
• Previous bilateral transiliac bone biopsies.

Trial design

105 participants in 4 patient groups

Alendronate 3 to < 5 years

Description:

Alendronate (any combination of 10 mg daily or 70 mg once weekly) 3- 5 years.

Risedronate 3 to < 5 Years

Description:

Risedronate (any combination of 5 mg daily or 35 mg once weekly) 3-5 years.

Alendronate ≥ 5 Years

Description:

Alendronate (any combination of 10 mg daily or 70 mg once weekly) for greater than or equal to 5 years.

Risedronate ≥ 5 Years

Description:

Risedronate (any combination of 5 mg daily or 35 mg once weekly) for greater than or equal to 5 years.