Radius Loading in Primary Hyperparathyroidism

Study Description

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Brief Summary:

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 or disease	Intervention/treatment	Phase
Primary Hyperparathyroidism; Bone Diseases, Metabolic; Osteoporosis, Postmenopausal; Bone Loss, Postmenopausal	Other: Forearm exercise program; Other: Walking program	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	12 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
Official Title:	Effect of Mechanical Loading on Radius Bone Density and Microarchitecture in Primary Hyperparathyroidism
Study Start Date :	February 2010
Actual Primary Completion Date :	October 2014
Actual Study Completion Date :	October 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
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

Outcome Measures

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Primary Outcome Measures :

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.

Eligibility Criteria

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Ages Eligible for Study:	45 Years and older (Adult, Senior)
Sexes 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

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Locations

United States, New York
Columbia University Medical Center
New York, New York, United States, 10032

Sponsors and Collaborators

Columbia University

National Institutes of Health (NIH)

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

Principal Investigator:	John P Bilezikian, M.D.	Columbia University

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Click here for more information about this study, "The Effect of Mechanical Loading on Radius Bone Density and Microarchitecture in Primary Hyperparathyroidism" 

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 ( U.S. NIH Grant/Contract )
First Posted:	April 5, 2012
Last Update Posted:	April 9, 2015
Last Verified:	April 2015

Keywords provided by John P. Bilezikian, 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