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Radius Loading in Primary Hyperparathyroidism

Primary Purpose

Primary Hyperparathyroidism, Bone Diseases, Metabolic, Osteoporosis, Postmenopausal

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Forearm exercise program
Walking program
Sponsored by
Columbia University
About
Eligibility
Locations
Arms
Outcomes
Full info

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

45 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Columbia University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Placebo Comparator

Active Comparator

Placebo Comparator

Arm Label

PHPT/ Walking + Forearm exercise

PHPT/ Walking alone

Osteopenia/ Walking + Forearm exercise

Osteopenia/ Walking alone

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
April 3, 2012
Last Updated
April 7, 2015
Sponsor
Columbia University
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT01571843
Brief Title
Radius Loading in Primary Hyperparathyroidism
Official Title
Effect of Mechanical Loading on Radius Bone Density and Microarchitecture in Primary Hyperparathyroidism
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
October 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Columbia University
Collaborators
National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Hyperparathyroidism, Bone Diseases, Metabolic, Osteoporosis, Postmenopausal, Bone Loss, Postmenopausal
Keywords
Hyperparathyroidism, Primary, Bone Diseases, Metabolic, Osteoporosis, Postmenopausal, Bone Loss, Postmenopausal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PHPT/ Walking + Forearm exercise
Arm Type
Experimental
Arm Description
Ten participants with PHPT will be randomized to the intervention of 52 weeks of the forearm exercise program plus walking.
Arm Title
PHPT/ Walking alone
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Osteopenia/ Walking + Forearm exercise
Arm Type
Active Comparator
Arm Description
Ten healthy, postmenopausal women with osteopenia will be randomized to the intervention of 52 weeks of the forearm exercise program plus walking.
Arm Title
Osteopenia/ Walking alone
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Forearm exercise program
Other Intervention Name(s)
Mechanical Loading
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Walking program
Other Intervention Name(s)
Walking
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of subjects with improved bone mass and bone quality at the 1/3 radius
Description
The primary outcome is proportion of subjects with improved bone mass and bone quality at the 1/3 radius over one year.
Time Frame
1 year

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John P Bilezikian, M.D.
Organizational Affiliation
Columbia University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.columbiamedicine.org/divisions/Endo/index.shtml
Description
Click here for more information about this study, "The Effect of Mechanical Loading on Radius Bone Density and Microarchitecture in Primary Hyperparathyroidism"

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Radius Loading in Primary Hyperparathyroidism

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