Phase 4
N=109
Effect of Bisphosphonate on Bone Loss in Postmenopausal Women With Breast Cancer Initiating Aromatase Inhibitor Therapy
Bone Loss · Osteoporosis · Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT00485953 ↗Enrolled (actual)
109
Serious AEs
23.8%
Results posted
Jul 2014
Primary outcome: Primary: BMD of Spine by DXA — 2.269; -1.735 percentage change
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- risedronate (Drug)
- Age
- Adult, Older Adult · 55+ yrs
- Sex
- Female
- Sponsor
- Susan L. Greenspan
- Primary completion
- Mar 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY BMD of Spine by DXA |
2.269; -1.735 | — |
| SECONDARY BMD by DXA at the Femoral Neck and Total Hip |
0.558; -2.748; 0.408; -2.137 | — |
| SECONDARY Markers of Bone Resorption and Bone Formation |
-14.906; -4.077; -46.863; -1.630 | — |
Summary
Elderly, postmenopausal women with breast cancer on aromatase inhibitors are at increased risk of developing bone loss and osteoporosis. We postulate that in elderly, osteopenic postmenopausal women who are on aromatase inhibitor therapy, bisphosphonate therapy will (1) prevent bone loss at clinically relevant sites, such as the spine and hip and (2) decrease bone turnover.
Eligibility Criteria
Inclusion Criteria
- elderly postmenopausal women (ages 55 and older)
- osteopenic (DXA T-score -1.0 to -2.5 SD). However, after full counseling about the risks, benefits, and options regarding therapy for osteoporosis and discussion with her PCP, an osteoporotic woman may enroll in the study.
- with breast cancer on aromatase inhibitor therapy
- with no evidence of distant metastatic disease or osteoporosis (by BMD or clinical history)
- type of surgical procedure or addition of radiation therapy prior to this aromatase inhibitor therapy will not exclude patients
- Participants must provide voluntary, written informed consent to participate in the study, which includes understanding of the procedures, medications, and risks and benefits
Exclusion Criteria
- Women with stage 4 breast cancer (presence of distant metastases)
- Women with normal bone density by DXA (T-score > -1.0 SD)bone density by DXA, except in the instance of a fragility fracture.
- Women with history of any illness known to affect bone and mineral metabolism, such as renal failure (estimated GFR 3 months for suppression therapy, and certain anti-seizure medications which may adversely affect bone metabolism (phenobarbital, phenytoin, carbamazepine).
- Those with untreated active peptic ulcer disease
- Those with osteoporosis by BMD (T-score -2.5 SD at the spine or total hip) or a history of fragility fracture as an adult. However, as discussed above, osteoporotic women may elect to enroll in the study.
- Women treated with oral bisphosphonates or calcitonin for 3 months within the last year (3 month washout period)
- Men and children will be excluded because they do not get postmenopausal osteoporosis following treatment with an aromatase inhibitor
- Women with very poor dental hygiene (as assessed by the baseline dental exam) in need of dental extraction during the study
- Use of fluoride for more than 1 month ever (except for dental treatment)
- Less than 2 evaluable vertebrae
- Distant metastatic disease
Data sourced from ClinicalTrials.gov (NCT00485953). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.