Status:
WITHDRAWN
The Effects of Alendronate After Cure of Primary Hyperparathyroidism
Lead Sponsor:
Columbia University
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Hyperparathyroidism
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
We are investigating whether, after surgical cure of primary hyperparathyroidism, alendronate provides even greater beneficial skeletal effects than parathyroidectomy alone. Primary Hyperparathyroidi...
Detailed Description
Study Purpose: Hypothesis: After successful surgical cure of primary hyperparathyroidism alendronate provides even greater beneficial skeletal effects than parathyroidectomy alone. Primary hyperpara...
Eligibility Criteria
Inclusion
- patients with PHPT who have a negative T-score by BMD at the lumbar spine before surgery;
- successful surgery for PHPT as documented by normalization of serum calcium and PTH levels within 1 week of study initiation.
Exclusion
- vitamin D deficiency;
- any concomitant disease that might affect mineral metabolism such as hyperthyroidism, Paget's disease of bone, diabetes mellitus, chronic liver or renal disease, acromegaly, Cushing's syndrome, rheumatoid arthritis, myeloma;
- any woman who is within 5 years of the menopause;
- gastrointestinal disorders, surgery or drugs affecting absorption;
- treatment with a bisphosphonate within 2 years of parathyroidectomy;
- treatment with any of the following medications more recently than 6 months prior to enrollment: estrogens, progestins, raloxifene, calcitonin, systemic corticosteroids, fluoride, lithium, loop diuretics, methotrexate;
- abnormalities of the esophagus which delay esophageal emptying such as stricture or achalasia;
- inability to stand or sit upright for at least 30 minutes;
- increased risk of aspiration;
- hypersensitivity to alendronate;
- hypocalcemia;
- pregnancy or nursing; (women within childbearing years will be advised not to conceive during the study);
- age \< 18 years old.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00359385
Start Date
July 1 2006
End Date
September 1 2009
Last Update
November 16 2011
Active Locations (1)
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1
CUMC
New York, New York, United States, 10032