Brief Summary

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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

105

participants targeted

Target at P50-P75 for all trials

Timeline

Completed

Started Jan 2004

Typical duration for all trials

Geographic Reach

2 countries

8 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.9 years study duration

Study Start

First participant enrolled

January 1, 2004

Completed

2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2006

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed

1.9 years until next milestone

First Submitted

Initial submission to the registry

October 21, 2008

Completed

2 days until next milestone

First Posted

Study publicly available on registry

October 23, 2008

Completed

Last Updated

June 5, 2013

Status Verified

June 1, 2013

Enrollment Period

2.9 years

First QC Date

October 21, 2008

Last Update Submit

June 3, 2013

Conditions

Postmenopausal Osteoporosis

Outcome Measures

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
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
one year

Study Arms (4)

Alendronate 3 to < 5 years

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

Risedronate 3 to < 5 Years

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

Alendronate ≥ 5 Years

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

Risedronate ≥ 5 Years

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

Eligibility Criteria

Sexfemale

Healthy VolunteersNo

Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Outpatients from bone research centers who have taken alendronate or risedronate for 3 to 5 or more years

You may qualify if:

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.

You may not qualify if:

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.

Contact the study team to confirm eligibility.