Radius Loading in Primary Hyperparathyroidism
This study has been completed.
Sponsor:
Columbia University
Collaborators:
National Institutes of Health (NIH)
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
John P. Bilezikian, Columbia University
ClinicalTrials.gov Identifier:
NCT01571843
First received: April 3, 2012
Last updated: April 7, 2015
Last verified: April 2015
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 |
|---|---|
|
Primary Hyperparathyroidism 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:
Genetics Home Reference related topics:
familial isolated hyperparathyroidism
hyperparathyroidism-jaw tumor syndrome
U.S. FDA Resources
Further study details as provided by Columbia University:
Primary Outcome Measures:
- Proportion of subjects with improved bone mass and bone quality at the 1/3 radius [ 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.
| Enrollment: | 12 |
| Study Start Date: | February 2010 |
| Study Completion Date: | October 2014 |
| Primary Completion Date: | October 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 (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
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.
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01571843
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
Additional Information:
| 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: | April 7, 2015 |
| Health Authority: | United States: Food and Drug Administration 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 30, 2016