Primary HyperparathyroidismPhase 2/3NCT01329666
Primary Hyperparathyroidism (PHPT): Early Effect of Vitamin D
A Phase 2/3 study testing Vitamin D3 in people with Primary Hyperparathyroidism and Hypercalcemia, run by Columbia University at 1 site in United States.
Trial summary
Primary hyperparathyroidism (PHPT) is a common disease that occurs in 1 in 10,000 people every year. In the presence of this condition, the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Primary Hyperparathyroidism, Hypercalcemia, Vitamin D Deficiency
- What is being tested?
- Vitamin D3
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jan 2015
- Phase
- Phase 2/3
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Females and males >= 45 years of age
- PHPT, defined as elevated PTH with elevated serum calcium
- Screening 25-OHD <= 20 ng/ml
Who cannot join
- Pre-menopausal
- Serum calcium is >11.5mg/dl.
- Urinary calcium is >350 mg/dl.
- Active nephrolithiasis
- Nephocalcinosis
- Known sensitivity to tetracycline (Sumycin)
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- Familial history of hyperparathyroid syndromes
- Bisphosphonate use within past 2 years.
- Current use of Prolia.
- Current use of Cinacalcet.
- Currently using Cimetidine.
- Currently use Colestipol.
- Currently using Orlistat.
- Current or past malignancy, except cured basal or squamous cell skin carcinoma or other cancers that have not recurred for at least five years.
- Current tuberculosis, or history of Sarcoidosis, HIV/AIDS, chronic kidney disease (serum creatinine >= 1.5), liver disease, Crohn's Disease, Celiac Disease, or gastric bypass
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: Early Effect of Vitamin D in Primary Hyperparathyroidism
Primary hyperparathyroidism (PHPT) is a common disease that occurs in 1 in 10,000 people every year. In the presence of this condition, the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. The high levels of parathyroid hormone remove too much calcium from bones, and then deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by excess calcium loss which weakens bone structure. Other affected organs include the skeleton (calcium loss leads to a "weakening" of the skeleton), and the kidneys (high blood calcium can lead to kidney stones).
It is now evident that the majority of patients with even mild Primary Hyperparathyroidism are vitamin D deficient. In 2009, new international guidelines for the management of asymptomatic PHPT direct physicians to measure 25-hydroxyvitamin D (D3 or 25-OHD) in all patients, and to replete the reserve of vitamin D when the level is low (< 20 ng/ml). However, no recommendations for vitamin D repletion are given, because of limited data regarding the effects of vitamin D repletion, appropriate dosing and safety. Therefore, there is an urgent need for data upon which to base such recommendations, as well as are data on the effects of such treatment upon bones.
Read more
Subjects with low vitamin D3 levels will be selected for this trial. They will be given enough vitamin D3 to raise their low blood levels from a low to a normal range. The assessments in this study, including the quadruple label bone biopsy, will allow us to document the short term effects of administering vitamin D3 on changes in bone.
All participants enrolled in this trial will be vitamin D3 deficient. Participants will take an antibiotic (tetracycline) 4 times a day to mark the starting point from which bone changes will be assessed. After 3 days of tetracycline, a 12 week course of vitamin D3 or placebo will be initiated. Six of 7 participants will receive the study drug (active vitamin D3), while 1 in 7 will receive a placebo (sugar pill). Ten weeks later, another 3-day course of tetracycline will be given. At the end of 12 weeks, a bone biopsy will be done. A small piece of bone (about the size of a pencil eraser) will be removed from the hip (iliac crest). The bone will be analyzed to determine the effect of vitamin D3 on primary hyperparathyroidism.
There will be 4 study visits: Screening, Baseline, Week 8, and Week 12 when the bone biopsy will be performed.
Study Procedures:
Medical and Social History
Blood tests (drawn at the study center and local Quest Lab)
24-Hour urine collection for calcium and creatinine excretion
Abdominal X-ray (to assess for kidney stones)
Transiliac crest Bone Biopsy
- Conditions
- Primary Hyperparathyroidism, Hypercalcemia, Vitamin D Deficiency, Osteoporosis, Osteopenia
- Being tested
- Placebo, Vitamin D3
- Keywords
- Primary Hyperparathyroidism, Endocrinology, Hypercalcemia, Vitamin D deficiency, Parathyroid Hormone, Osteoporosis, Bone Density, Vitamin D repletion, Vitamin D Supplements
- Medical subject headings
- Hyperparathyroidism, Primary, Hypercalcemia, Vitamin D Deficiency, Osteoporosis, Bone Diseases, Metabolic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDietary supplement
Subjects will receive placebo vitamin D3, 1 pill weekly for 12 weeks.
Vitamin D3Dietary supplement
Baseline:
50,000 IU/week for 8 weeks
Week 8:
Subjects with D3 less than 30 ng/ml: 50,000 IU/week for 4 weeks.
Subjects with D3 25-OHD at or above 30 ng/ml: 50,000 IU/every 2 weeks for 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| 50,000 IU Vitamin D3 | Experimental | Not described Receives: Dietary Supplement: Vitamin D3 |
| Placebo (inactive Vitamin D3) | Placebo comparator | Not described Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Bone Formation Rate (BFR)
A between group (vitamin D3 vs. placebo) comparison of BFR will be performed at three surfaces, cancellous, intra- and endo-cortical.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2011 (estimated)
- Study startMay 2010
- Primary completionJan 2015
- Study completionJan 2015
Why it stopped: Poor enrollment
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 2/3
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Columbia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shonni J. Silverberg, Columbia University
- Investigators
- Shonni J. Silverberg, MD, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01329666
- Sponsor's protocol ID
- AAAF1846
- Other IDs
- R01DK084986
- Status last verified
- Mar 2015
- First submitted
- 4 Apr 2011
- Last updated
- 5 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Effect of Vitamin D in Primary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT01329666
- Acronym / sponsor ID
- AAAF1846
- Conditions
- Primary Hyperparathyroidism, Hypercalcemia, Vitamin D Deficiency, Osteoporosis, Osteopenia
- Keywords
- Primary Hyperparathyroidism, Endocrinology, Hypercalcemia, Vitamin D deficiency, Parathyroid Hormone, Osteoporosis, Bone Density, Vitamin D repletion
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Poor enrollment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Columbia UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2010
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 6 Apr 2011 (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.
Primary hyperparathyroidism (PHPT) is a common disease that occurs in 1 in 10,000 people every year. In the presence of this condition, the parathyroid glands produce excessive amounts of parathyroid hormone (PTH), which regulates calcium levels. The high levels of parathyroid hormone remove too much calcium from bones, and then deposit the excess calcium in the blood, which is then filtered into the urine by the kidneys. Bone health is threatened by excess calcium loss which weakens bone structure. Other affected organs include the skeleton (calcium loss leads to a "weakening" of the skeleton), and the kidneys (high blood calcium can lead to kidney stones).
It is now evident that the majority of patients with even mild Primary Hyperparathyroidism are vitamin D deficient. In 2009, new international guidelines for the management of asymptomatic PHPT direct physicians to measure 25-hydroxyvitamin D (D3 or 25-OHD) in all patients, and to replete the reserve of vitamin D when the level is low (< 20 ng/ml). However, no recommendations for vitamin D repletion are given, because of limited data regarding the effects of vitamin D repletion, appropriate dosing and safety. Therefore, there is an urgent need for data upon which to base such recommendations, as well as are data on the effects of such treatment upon bones.
Subjects with low vitamin D3 levels will be selected for this trial. They will be given enough vitamin D3 to raise their low blood levels from a low to a normal range. The assessments in this study, including the quadruple label bone biopsy, will allow us to document the short term effects of administering vitamin D3 on changes in bone.
All participants enrolled in this trial will be vitamin D3 deficient. Participants will take an antibiotic (tetracycline) 4 times a day to mark the starting point from which bone changes will be assessed. After 3 days of tetracycline, a 12 week course of vitamin D3 or placebo will be initiated. Six of 7 participants will receive the study drug (active vitamin D3), while 1 in 7 will receive a placebo (sugar pill). Ten weeks later, another 3-day course of tetracycline will be given. At the end of 12 weeks, a bone biopsy will be done. A small piece of bone (about the size of a pencil eraser) will be removed from the hip (iliac crest). The bone will be analyzed to determine the effect of vitamin D3 on primary hyperparathyroidism.
There will be 4 study visits: Screening, Baseline, Week 8, and Week 12 when the bone biopsy will be performed.
Study Procedures:
Medical and Social History
Blood tests (drawn at the study center and local Quest Lab)
24-Hour urine collection for calcium and creatinine excretion
Abdominal X-ray (to assess for kidney stones)
Transiliac crest Bone Biopsy
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50,000 IU Vitamin D3 | Experimental | Dietary Supplement: Vitamin D3 |
| Placebo (inactive Vitamin D3) | Placebo comparator | Dietary Supplement: Placebo |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Females and males >= 45 years of age
- PHPT, defined as elevated PTH with elevated serum calcium
- Screening 25-OHD <= 20 ng/ml
Key exclusion criteria (15 listed)
- Pre-menopausal
- Serum calcium is >11.5mg/dl.
- Urinary calcium is >350 mg/dl.
- Active nephrolithiasis
- Nephocalcinosis
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 |
|---|---|---|
| PlaceboSubjects will receive placebo vitamin D3, 1 pill weekly for 12 weeks. | Dietary supplement | Placebo (inactive Vitamin D3) |
| Vitamin D3Baseline: 50,000 IU/week for 8 weeks Week 8: Subjects with D3 less than 30 ng/ml: 50,000 IU/week for 4 weeks. Subjects with D3 25-OHD at or above 30 ng/ml: 50,000 IU/every 2 weeks for 4 weeks. | Dietary supplement | 50,000 IU Vitamin D3 |
Primary outcome
Change in Bone Formation Rate (BFR)
Time frame: 12 Weeks
A between group (vitamin D3 vs. placebo) comparison of BFR will be performed at three surfaces, cancellous, intra- and endo-cortical.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2015.
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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.
Shonni J. Silverberg, MD 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 Phase 2/3 study testing Vitamin D3 in people with Primary Hyperparathyroidism and Hypercalcemia, 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 3 inclusion and 15 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: withdrawn, as of the sponsor's last update on 5 Mar 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Change in Bone Formation Rate (BFR) (time frame: 12 Weeks). 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 5 Mar 2015; AzTrials last refreshed its copy on 4 Nov 2026.