NCT00359385

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2006

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2006

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

August 1, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 2, 2006

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

November 16, 2011

Status Verified

November 1, 2011

Enrollment Period

3.2 years

First QC Date

August 1, 2006

Last Update Submit

November 15, 2011

Conditions

Hyperparathyroidism

Keywords

primary hyperparathyroidismhyperparathyroidismPHPTPTHhypercalcemiabone densityosteoporosisbone turnoverDXApQCTcQCTalendronateFosamaxparathyroid hormoneparathyroid surgeryparathyroidectomySilverbergRubinBilezikiantreatment

Outcome Measures

Primary Outcomes (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.

    July 2009

Secondary Outcomes (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.

    July 2009

Study Arms (2)

Alendronate 70mg weekly

ACTIVE COMPARATOR

Alendronate 70mg weekly

Drug: Alendronate 70mg weekly

placebo of alendronate 70mg weekly

PLACEBO COMPARATOR

placebo of Alendronate 70mg weekly

Drug: Alendronate 70mg weekly

Interventions

Alendronate 70mg weeklyDRUG

70mg weekly

Also known as: Fosamax
Alendronate 70mg weeklyplacebo of alendronate 70mg weekly

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CUMC

New York, New York, 10032, United States

Location

MeSH Terms

Conditions

HyperparathyroidismHyperparathyroidism, PrimaryHypercalcemiaOsteoporosis

Interventions

Alendronate

Condition Hierarchy (Ancestors)

Parathyroid DiseasesEndocrine System DiseasesCalcium Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesWater-Electrolyte ImbalanceBone Diseases, MetabolicBone DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

DiphosphonatesOrganophosphonatesOrganophosphorus CompoundsOrganic Chemicals

Study Officials

  • Shonni J. Silverberg, MD

    Columbia University

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 1, 2006

First Posted

August 2, 2006

Study Start

July 1, 2006

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

November 16, 2011

Record last verified: 2011-11

Locations

US(1)