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

This study has been withdrawn prior to enrollment.
(incomplete enrollment)
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Columbia University
ClinicalTrials.gov Identifier:
NCT00359385
First received: August 1, 2006
Last updated: November 15, 2011
Last verified: November 2011
  Purpose

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 Intervention Phase
Hyperparathyroidism
Drug: Alendronate 70mg weekly
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: The Effects of Alendronate After Cure of Primary Hyperparathyroidism

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: July 2006
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00359385

Locations
United States, New York
CUMC
New York, New York, United States, 10032
Sponsors and Collaborators
Columbia University
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Shonni J. Silverberg, MD Columbia University
  More Information

No publications provided

Responsible Party: Columbia University
ClinicalTrials.gov Identifier: NCT00359385     History of Changes
Other Study ID Numbers: AAAB8202
Study First Received: August 1, 2006
Last Updated: November 15, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Columbia University:
primary hyperparathyroidism
hyperparathyroidism
PHPT
PTH
hypercalcemia
bone density
osteoporosis
bone turnover
DXA
pQCT
cQCT
alendronate
Fosamax
parathyroid hormone
parathyroid surgery
parathyroidectomy
Silverberg
Rubin
Bilezikian
treatment

Additional relevant MeSH terms:
Hyperparathyroidism
Hyperparathyroidism, Primary
Endocrine System Diseases
Parathyroid Diseases
Alendronate
Bone Density Conservation Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 20, 2014