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Completed

NCT Number: NCT00778154

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

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.

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Key information

Conditions

Postmenopausal Osteoporosis Bone Diseases Bone Diseases, Metabolic Metabolic Diseases Musculoskeletal Diseases Nutritional and Metabolic Diseases Osteoporosis Osteoporosis, Postmenopausal

Sex eligibility

Female

Study type

Observational

Primary location

Warner Chilcott Research Facility, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Differences in iliac crest bone histomorphometry and bone quality 9microarchitecture and matrix structure in PMO women receiving long term therapy with alendronate or risedronate

    Time frame: one year

Secondary outcomes

  1. Compare iliac crest bone histomorphometry and bone quality changes after 5 years of more of alendronate or risedronate therapy with 3 years of therapy in PMO women

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Warner Chilcott

Industry

Collaborators

  • Sanofi

Registry information

Official study title

A Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Long-Term Alendronate or Risedronate

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Oct 23, 2008
Registry last updated
Jun 5, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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