Radius Loading in Primary Hyperparathyroidism
Effect of Mechanical Loading on Radius Bone Density and Microarchitecture in Primary Hyperparathyroidism
2 other identifiers
interventional
12
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 3, 2012
CompletedFirst Posted
Study publicly available on registry
April 5, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedApril 9, 2015
April 1, 2015
4.7 years
April 3, 2012
April 7, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Study Arms (4)
PHPT/ Walking + Forearm exercise
EXPERIMENTALTen participants with PHPT will be randomized to the intervention of 52 weeks of the forearm exercise program plus walking.
PHPT/ Walking alone
PLACEBO COMPARATORTen 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.
Osteopenia/ Walking + Forearm exercise
ACTIVE COMPARATORTen healthy, postmenopausal women with osteopenia will be randomized to the intervention of 52 weeks of the forearm exercise program plus walking.
Osteopenia/ Walking alone
PLACEBO COMPARATORTen 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.
Interventions
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 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.
Eligibility Criteria
You may qualify if:
- 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
- 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
- hydroxyvitamin D \>20 ng/mL
You may not qualify if:
- 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)
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Columbia University Medical Center
New York, New York, 10032, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
John P Bilezikian, M.D.
Columbia University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dorothy L. and Daniel H. Silberberg Professor of Medicine and Pharmacology
Study Record Dates
First Submitted
April 3, 2012
First Posted
April 5, 2012
Study Start
February 1, 2010
Primary Completion
October 1, 2014
Study Completion
October 1, 2014
Last Updated
April 9, 2015
Record last verified: 2015-04