Trial record 1 of 45 for:    "familial isolated hyperparathyroidism" OR "Hyperparathyroidism, Primary"
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Radius Loading in Primary Hyperparathyroidism

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2013 by Columbia University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
John P. Bilezikian, Columbia University
ClinicalTrials.gov Identifier:
NCT01571843
First received: April 3, 2012
Last updated: February 12, 2013
Last verified: February 2013
  Purpose

The purpose of the study is to determine the effect of forearm exercise on forearm bone density in post-menopausal women with or without primary hyperparathyroidism.

The investigators hypothesize that forearm exercise will increase forearm bone density in patients with primary hyperparathyroidism more so than in patients without primary hyperparathyroidism.


Condition Intervention
Hyperparathyroidism, Primary
Bone Diseases, Metabolic
Osteoporosis, Postmenopausal
Bone Loss, Postmenopausal
Other: Forearm exercise program
Other: Walking program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Mechanical Loading on Radius Bone Density and Microarchitecture in Primary Hyperparathyroidism

Resource links provided by NLM:


Further study details as provided by Columbia University:

Primary Outcome Measures:
  • Increase in bone mass and bone quality [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    The primary outcome is proportion of subjects with improved bone mass and bone quality at the 1/3 radius over one year.


Estimated Enrollment: 40
Study Start Date: February 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PHPT/ Walking + Forearm exercise
Ten participants with PHPT will be randomized to the intervention of 52 weeks of the forearm exercise program plus walking.
Other: Forearm exercise program
Participants assigned to forearm exercise will receive training in forearm strengthening exercises from a doctoral occupational therapy student. Participants will be taught 8 exercises and are performed at home. The exercise program is designed to take about 30 minutes per session.
Other Name: Mechanical Loading
Placebo Comparator: PHPT/ Walking alone
Ten participants with PHPT will be randomized to the intervention of 52 weeks of the walking program alone. Walking will consist of 30 minutes at a moderate pace every other day for 52 weeks.
Other: Walking program
Walking will consist of 30 minutes at a moderate pace every other day for 52 weeks. The walking program for all participants constitutes the control/placebo comparator.
Other Name: Walking
Active Comparator: Osteopenia/ Walking + Forearm exercise
Ten healthy, postmenopausal women with osteopenia will be randomized to the intervention of 52 weeks of the forearm exercise program plus walking.
Other: Forearm exercise program
Participants assigned to forearm exercise will receive training in forearm strengthening exercises from a doctoral occupational therapy student. Participants will be taught 8 exercises and are performed at home. The exercise program is designed to take about 30 minutes per session.
Other Name: Mechanical Loading
Placebo Comparator: Osteopenia/ Walking alone
Ten healthy, postmenopausal women with osteopenia will be randomized to the intervention of 52 weeks of the walking program alone. Walking will consist of 30 minutes at a moderate pace every other day for 52 weeks.
Other: Walking program
Walking will consist of 30 minutes at a moderate pace every other day for 52 weeks. The walking program for all participants constitutes the control/placebo comparator.
Other Name: Walking

Detailed Description:

Primary hyperparathyroidism (PHPT), a disease characterized by excess parathyroid hormone (PTH) and high blood calcium, is one of the most common endocrine disorders.

PHPT is seen most often in post-menopausal women. Kidney stones and bone deformities were prominent manifestations of the disease in the past, however, PHPT is now primarily asymptomatic due to incidental detection of high blood calcium levels.

Many patients with PHPT, however, have low bone mineral density (BMD) when bone mass is measured by dual energy x-ray absorptiometry (DXA), primarily at the forearm.

There is no effective medical therapy which increases bone density at the forearm in patients with PHPT. PTH both builds and breaks down bone, and the pathways by which PTH mediates these actions are beginning to be identified. Prior research suggests that mechanical loading shifts PTH towards building bone. Arm exercise is an attractive option for the treatment of low forearm BMD in patients with PHPT since it is often the site most affected by excess PTH.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Inclusion criteria for primary hyperparathyroidism group:

  1. Primary hyperparathyroidism (defined by an elevated serum calcium and concomitantly elevated or inappropriately normal PTH)
  2. Female sex, postmenopausal status for at least five years, ages 45-80
  3. English- or Spanish-speaking
  4. DXA T-score less than -1.0 at the one-third radius
  5. Physically capable of exercise
  6. 25-hydroxyvitamin D >20 ng/mL. The latter inclusion criterion will lead to the enrollment of some individuals whose vitamin D stores will not be frankly low. We feel, however, that it is better to study subjects in their usual state rather than replacing them with vitamin D which could add another variable that would further complicate this pilot study.

Inclusion criteria for the osteopenic control:

  1. Female sex, postmenopausal status for at least five years ages 45-80
  2. English- or Spanish-speaking
  3. DXA T-score less than -1.0 at the one-third radius
  4. Physically capable of exercise
  5. Normal serum calcium and PTH level
  6. 25-hydroxyvitamin D >20 ng/mL

Exclusion Criteria:

  1. Men, premenopausal women, women less than age 45 or greater than age 80
  2. Familial hypocalciuric hypercalcemia
  3. Current or prior use of bisphosphonates (alendronate or risedronate (within 12 months), ibandronate (within 6 months), other bisphosphonate (2 years)
  4. Current use of cinacalcet
  5. Current or prior use of estrogen replacement therapy (within 2 years)
  6. Planned parathyroidectomy (within one year)
  7. Planned initiation of bisphosphonates
  8. DXA T-score greater than -1.0 at the one-third radius
  9. Cardiovascular disease or uncontrolled hypertension
  10. Exercise-limiting pulmonary diseases
  11. Malignancy other than non-melanomatous skin cancer or microscopic thyroid cancer (within 5 years)
  12. Renal failure
  13. Secondary hyperparathyroidism
  14. Celiac disease
  15. Physical/orthopedic disabilities and neurologic disorders or vasculopathies that would place the subjects at risk or limit their ability to perform exercise (eg. arthritis, carpal tunnel syndrome, rotator cuff injury, etc)
  16. Moderate or high physical activity (category 2 or 3) as assessed by the IPAQ questionnaire. This latter exclusion criterion is a measure of baseline physical activity and looks to exclude those who would have a lower likelihood of benefit by baseline participation in an exercise program.
  17. Protected individuals (institutionalized), prisoners, and any other prospective participant who might not be able to give voluntary informed consent.
  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: NCT01571843

Contacts
Contact: Megan E Romano 2123047254 mr647@columbia.edu

Locations
United States, New York
Columbia University Medical Center Recruiting
New York, New York, United States, 10032
Contact: Megan E Romano    212-304-7254    mr647@columbia.edu   
Principal Investigator: John P Bilezikian, M.D.         
Sponsors and Collaborators
Columbia University
Investigators
Principal Investigator: John P Bilezikian, M.D. Columbia University
  More Information

Additional Information:
No publications provided

Responsible Party: John P. Bilezikian, Dorothy L. and Daniel H. Silberberg Professor of Medicine and Pharmacology, Columbia University
ClinicalTrials.gov Identifier: NCT01571843     History of Changes
Other Study ID Numbers: AAAE6548, R01DK032333
Study First Received: April 3, 2012
Last Updated: February 12, 2013
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by Columbia University:
Hyperparathyroidism, Primary
Bone Diseases, Metabolic
Osteoporosis, Postmenopausal
Bone Loss, Postmenopausal

Additional relevant MeSH terms:
Osteoporosis
Hyperparathyroidism
Bone Diseases
Hyperparathyroidism, Primary
Osteoporosis, Postmenopausal
Metabolic Diseases
Bone Diseases, Metabolic
Musculoskeletal Diseases
Parathyroid Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 18, 2014