Primary HyperparathyroidismNCT01571843
Radius Loading in Primary Hyperparathyroidism
A study testing Forearm exercise program and Walking program in people with Primary Hyperparathyroidism and Bone Diseases, Metabolic, run by Columbia University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 45 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Primary Hyperparathyroidism, Bone Diseases, Metabolic, Osteoporosis, Postmenopausal
- What is being tested?
- Forearm exercise program and Walking program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2010to Oct 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Show all 12Show fewer
- 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
Who cannot join
- 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)
Show all 17Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Columbia University Medical Center
New York, New York, 10032
About this study
Official title: Effect of Mechanical Loading on Radius Bone Density and Microarchitecture in Primary Hyperparathyroidism
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.
Read the 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.
- Conditions
- Primary Hyperparathyroidism, Bone Diseases, Metabolic, Osteoporosis, Postmenopausal, Bone Loss, Postmenopausal
- Being tested
- Forearm exercise program, Walking program
- Keywords
- Hyperparathyroidism, Primary, Bone Diseases, Metabolic, Osteoporosis, Postmenopausal, Bone Loss, Postmenopausal
- Medical subject headings
- Hyperparathyroidism, Primary, Bone Diseases, Metabolic, Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Forearm exercise programOther
Also called Mechanical Loading
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 programOther
Also called Walking
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.
| Study group | Role | What they receive |
|---|---|---|
| PHPT/ Walking + Forearm exercise | Experimental | Ten participants with PHPT will be randomized to the intervention of 52 weeks of the forearm exercise program plus walking. Receives: Other: Forearm exercise program |
| PHPT/ Walking alone | Placebo comparator | 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. Receives: Other: Walking program |
| Osteopenia/ Walking + Forearm exercise | Active comparator | Ten healthy, postmenopausal women with osteopenia will be randomized to the intervention of 52 weeks of the forearm exercise program plus walking. Receives: Other: Forearm exercise program |
| Osteopenia/ Walking alone | Placebo comparator | 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. Receives: Other: Walking program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2012 (estimated)
- Study startFeb 2010
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Columbia UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, John P. Bilezikian, Columbia University
- Investigators
- John P Bilezikian, M.D., Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01571843
- Sponsor's protocol ID
- AAAE6548
- Other IDs
- R01DK032333
- Status last verified
- Apr 2015
- First submitted
- 3 Apr 2012
- Last updated
- 9 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Mechanical Loading on Radius Bone Density and Microarchitecture in Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT01571843
- Acronym / sponsor ID
- AAAE6548
- Conditions
- Primary Hyperparathyroidism, Bone Diseases, Metabolic, Osteoporosis, Postmenopausal, Bone Loss, Postmenopausal
- Keywords
- Hyperparathyroidism, Primary, Bone Diseases, Metabolic, Osteoporosis, Postmenopausal, Bone Loss, Postmenopausal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- Feb 2010
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 5 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PHPT/ Walking + Forearm exercise | Experimental | Other: Forearm exercise programTen participants with PHPT will be randomized to the intervention of 52 weeks of the forearm exercise program plus walking. |
| PHPT/ Walking alone | Placebo comparator | Other: Walking programTen 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 comparator | Other: Forearm exercise programTen 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 comparator | Other: Walking programTen 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. |
Who may qualify
- Ages
- 45 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Forearm exercise programAlso: Mechanical LoadingParticipants 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 | Osteopenia/ Walking + Forearm exercise, PHPT/ Walking + Forearm exercise |
| Walking programAlso: WalkingWalking 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 | Osteopenia/ Walking alone, PHPT/ Walking alone |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Apr 2015.
- Click here for more information about this study, "The Effect of Mechanical Loading on Radius Bone Density and Microarchitecture in Primary Hyperparathyroidism"Link provided by the sponsor.
Related trials for Primary Hyperparathyroidism
RecruitingPhase 4
Bisphosphonate Prior to Parathyroidectomy in Primary Hyperparathyroidism
Primary Hyperparathyroidism
Not yet recruitingObservational study
Osteoporosis & Renal Disease: Research in Primary Health Care Services
Osteoporosis, Chronic Kidney Disease Mineral and Bone Disorder
RecruitingObservational study
Evaluation of the Role of Luteinizing Hormone (LH) and Human Chorionic Gonadotropin (hCG) in Adult Patients Undergoing Assessment for Endocrine Disorders
Osteoporosis, Hypercalcemia
RecruitingObservational study
Natural History Study of Parathyroid Disorders
Parathyroid Cancer, Primary Hyperparathyroidism
Recruiting
NIRAF-camera Versus Conventional Surgery in Preoperative Imaging Negative Primary Hyperparathyroidism
Primary Hyperparathyroidism
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John P Bilezikian, M.D. principal investigator
Columbia University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Forearm exercise program and Walking program in people with Primary Hyperparathyroidism and Bone Diseases, Metabolic, run by Columbia University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects with improved bone mass and bone quality at the 1/3 radius (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Apr 2015.