Clinical trial NCT00778154: Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Alendronate or Risedronate
Official title: A Study of Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Long-Term Alendronate or Risedronate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Warner Chilcott
Sponsor class: INDUSTRY
Collaborators: name: Sanofi
First posted: 2008-10-23
Enrollment: 105
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Outpatients from bone research centers who have taken alendronate or risedronate for 3 to 5 or more years

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Differences in iliac crest bone histomorphometry and bone quality 9microarchitecture and matrix structure in PMO women receiving long term therapy with alendronate or risedronate
timeFrame: one year
Secondary outcomes:
measure: 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
timeFrame: one year
Other outcomes:
Locations:
city: Palm Desert
country: United States
facility: Warner Chilcott Research Facility
state: California
city: Lakewood
country: United States
facility: Warner Chilcott Research Facility
state: Colorado
city: Decatur
country: United States
facility: Warner Chilcott Research Facility
state: Georgia
city: Gainesville
country: United States
facility: Warner Chilcott Research Facility
state: Georgia
city: Omaha
country: United States
facility: Warner Chilcott Research Facility
state: Nebraska
city: Cincinnati
country: United States
facility: Warner Chilcott Research Facility
state: Ohio
city: Wyomissing
country: United States
facility: Warner Chilcott Research Facility
state: Pennsylvania
city: Montreal
country: Canada
facility: Warner Chilcott Research Facility
state: Quebec
Study officials:
affiliation: Procter and Gamble
name: Stephen R Marcello, MD
role: STUDY_DIRECTOR
References: