Radius Loading in Primary Hyperparathyroidism
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT01571843 |
|
Recruitment Status :
Completed
First Posted : April 5, 2012
Last Update Posted : April 9, 2015
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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 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 |
| 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 |
- 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.
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, Learn About Clinical Studies.
| Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01571843
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| Principal Investigator: | John P Bilezikian, M.D. | Columbia University |
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 ( U.S. NIH Grant/Contract ) |
| First Posted: | April 5, 2012 Key Record Dates |
| 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 |