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The Effects of Alendronate After Cure of Primary Hyperparathyroidism (AlenPostPara)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00359385
Recruitment Status : Withdrawn (incomplete enrollment)
First Posted : August 2, 2006
Last Update Posted : November 16, 2011
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Columbia University

Brief 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.

Condition or disease Intervention/treatment Phase
Hyperparathyroidism Drug: Alendronate 70mg weekly Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Alendronate After Cure of Primary Hyperparathyroidism
Study Start Date : July 2006
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Active Comparator: Alendronate 70mg weekly
Alendronate 70mg weekly
Drug: Alendronate 70mg weekly
70mg weekly
Other Name: Fosamax

Placebo Comparator: placebo of alendronate 70mg weekly
placebo of Alendronate 70mg weekly
Drug: Alendronate 70mg weekly
70mg weekly
Other Name: Fosamax

Primary Outcome Measures :
  1. To investigate the effects of alendronate on bone mineral density using data on changes at the lumbar spine, the hip and distal 1/3 radius. The rate of change in BMD at these sites will also be determined by BMD. [ Time Frame: July 2009 ]

Secondary Outcome Measures :
  1. We also intend to determine whether alendronate alters bone turnover to maximize the augmented window defined by a rapid fall in bone resorption and a slower fall in bone formation. [ Time Frame: July 2009 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00359385

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United States, New York
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Merck Sharp & Dohme Corp.
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Principal Investigator: Shonni J. Silverberg, MD Columbia University
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Responsible Party: Columbia University Identifier: NCT00359385    
Other Study ID Numbers: AAAB8202
First Posted: August 2, 2006    Key Record Dates
Last Update Posted: November 16, 2011
Last Verified: November 2011
Keywords provided by Columbia University:
primary hyperparathyroidism
bone density
bone turnover
parathyroid hormone
parathyroid surgery
Additional relevant MeSH terms:
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Hyperparathyroidism, Primary
Parathyroid Diseases
Endocrine System Diseases
Bone Density Conservation Agents
Physiological Effects of Drugs