Radius Loading in Primary Hyperparathyroidism

Osteoporosis, Postmenopausal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01571843
• Other study ID #: AAAE6548
• Secondary ID: R01DK032333
• Status: Completed
• Phase: N/A
• First received: April 3, 2012
• Last updated: April 7, 2015
• Start date: February 2010
• Est. completion date: October 2014

Study information

• Verified date: April 2015
• Source: Columbia University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 45 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bone Diseases
• Bone Diseases, Metabolic
• Bone Loss, Postmenopausal
• Hyperparathyroidism
• Hyperparathyroidism, Primary
• Metabolic Diseases
• Osteoporosis
• Osteoporosis, Postmenopausal
• Primary Hyperparathyroidism

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Columbia University Medical Center	New York	New York

Sponsors (3)

Lead Sponsor	Collaborator
Columbia University	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects with improved bone mass and bone quality at the 1/3 radius	The primary outcome is proportion of subjects with improved bone mass and bone quality at the 1/3 radius over one year.	1 year	No

External Links

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