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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postmenopausal Osteoporosis

Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Alendronate 3 to < 5 years<br>Alendronate (any combination of 10 mg daily or 70 mg once weekly) 3- 5 years. | |
| Risedronate 3 to < 5 Years<br>Risedronate (any combination of 5 mg daily or 35 mg once weekly) 3-5 years. | |
| Alendronate ≥ 5 Years<br>Alendronate (any combination of 10 mg daily or 70 mg once weekly) for greater than or equal to 5 years. | |
| Risedronate ≥ 5 Years<br>Risedronate (any combination of 5 mg daily or 35 mg once weekly) for greater than or equal to 5 years. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in iliac crest bone histomorphometry and bone quality 9microarchitecture and matrix structure in PMO women receiving long term therapy with alendronate or risedronate |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  | one year |