The Effects of Alendronate After Cure of Primary Hyperparathyroidism

• Status: Withdrawn
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

Summary

We are investigating whether, after surgical cure of primary hyperparathyroidism, alendronate provides even greater beneficial skeletal effects than parathyroidectomy alone.

Primary Hyperparathyroidism (PHPT) is a disorder that can be associated with bone loss. After successful surgery for PHPT bone density improves without any treatment. However, it is possible that bone density might improve to an even greater extent if Fosamax is used after the surgical cure. Fosamax is approved by the FDA for the prevention and treatment of osteoporosis, and the goal of this project is to determine whether after successful surgical cure of PHPT, Fosamax is even better for the skeleton than just parathyroid surgery alone.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Columbia University
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Alendronate

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.