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Completed

NCT Number: NCT01571843

Radius Loading in Primary Hyperparathyroidism

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.

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Key information

Age range

45 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Columbia University Medical Center

New York, 10032, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Inclusion criteria

for primary hyperparathyroidism group:

  • Primary hyperparathyroidism (defined by an elevated serum calcium and concomitantly elevated or inappropriately normal PTH)
  • Female sex, postmenopausal status for at least five years, ages 45-80
  • English- or Spanish-speaking
  • DXA T-score less than -1.0 at the one-third radius
  • Physically capable of exercise
  • 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:

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

Exclusion criteria

  • Men, premenopausal women, women less than age 45 or greater than age 80
  • Familial hypocalciuric hypercalcemia
  • Current or prior use of bisphosphonates (alendronate or risedronate (within 12 months), ibandronate (within 6 months), other bisphosphonate (2 years)
  • Current use of cinacalcet
  • Current or prior use of estrogen replacement therapy (within 2 years)
  • Planned parathyroidectomy (within one year)
  • Planned initiation of bisphosphonates
  • DXA T-score greater than -1.0 at the one-third radius
  • Cardiovascular disease or uncontrolled hypertension
  • Exercise-limiting pulmonary diseases
  • Malignancy other than non-melanomatous skin cancer or microscopic thyroid cancer (within 5 years)
  • Renal failure
  • Secondary hyperparathyroidism
  • Celiac disease
  • 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)
  • 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.
  • Protected individuals (institutionalized), prisoners, and any other prospective participant who might not be able to give voluntary informed consent.

Treatment and study plan

Forearm exercise program

Other

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 names: Mechanical Loading

Walking program

Other

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 names: Walking

Primary outcomes

  1. Proportion of subjects with improved bone mass and bone quality at the 1/3 radius

    Time frame: 1 year

    The primary outcome is proportion of subjects with improved bone mass and bone quality at the 1/3 radius over one year.

Sponsors and collaborators

Lead sponsor

Columbia University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
  • National Institutes of Health (NIH)

Registry information

Official study title

Effect of Mechanical Loading on Radius Bone Density and Microarchitecture in Primary Hyperparathyroidism

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 5, 2012
Registry last updated
Apr 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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