Radius Loading in Primary Hyperparathyroidism
Primary Hyperparathyroidism, Bone Diseases, Metabolic, Osteoporosis, Postmenopausal
About this trial
This is an interventional treatment trial for Primary Hyperparathyroidism focused on measuring Hyperparathyroidism, Primary, Bone Diseases, Metabolic, Osteoporosis, Postmenopausal, Bone Loss, Postmenopausal
Eligibility 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.
Sites / Locations
- Columbia University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Placebo Comparator
Active Comparator
Placebo Comparator
PHPT/ Walking + Forearm exercise
PHPT/ Walking alone
Osteopenia/ Walking + Forearm exercise
Osteopenia/ Walking alone
Ten participants with PHPT will be randomized to the intervention of 52 weeks of the forearm exercise program plus walking.
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.
Ten healthy, postmenopausal women with osteopenia will be randomized to the intervention of 52 weeks of the forearm exercise program plus walking.
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.