Age-Related OsteoporosisNCT01900860
Dose-dependent Effects of Vitamin D on Bone Health
A study testing Vitamin D in people with Age-Related Osteoporosis, run by University of Calgary at 1 site in Canada.
Trial summary
We propose to conduct a randomized double blind trial of three doses of vitamin D, 400, 4000, and 10,000 International Units (IU) per day, to assess the effect on bone density and architecture as assessed by high resolution peripheral quantitative tomography (HR-pQCT) measurements at the radius and distal tibia, and… Read more about this study
- Who is it for?
- Ages 55 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Age-Related Osteoporosis
- What is being tested?
- Vitamin D
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 311 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2013to 31 Dec 2017
- 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 55 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy women and men between 55 and 70 years of age; women will be at least 5 years post-menopause. Presence of a chronic illness does not exclude participation if the condition is stable and managed by a physician.
- Baseline lumbar spine and total hip bone mineral density (BMD) T-score above 2.5 as assessed using dual x-ray absorptiometry (DXA).
Who cannot join
- A serum 25-[OH] vitamin D (25OHD) of <30 nmol/L (<12 ng/mL) or >125 nmol/L (50 ng/mL).
- Hypercalcemia (serum calcium >2.55 mmol/L), hypocalcemia (serum calcium <2.10 mmol/L) or eGFR <30 mL/min.
- Surgical cure of Primary Hyperparathyroidism within the last year.
- Active kidney stone disease (recurrent stones, recent kidney stone [within last 2 years])
- Known hypersensitivity or allergy to Vitamin D
- Serum creatinine, AST, ALT, PTH, calcium, or alkaline phosphatase greater than 1.5 times the upper limit of normal at the screening visit
Show all 14Show fewer
- BMD exclusions:
- High 10-year risk for osteoporotic fracture, as defined by the Canadian Association of Radiologists/Osteoporosis Canada calculator, or the World Health Organization's FRAX calculator.
- DXA T-score below or equal to -2.5 SD.
- Have taken bone active osteoporosis prescription drugs in the past 2 years (bisphosphonates) or 1 year (other osteoporosis prescription therapies).
- Any medical condition that would prevent participation in a clinical trial for a full three years.
- Medications such as prednisone >2.5 mg daily (or equivalent); other bone active medications such as tamoxifen or aromatase inhibitors for breast cancer, or androgen deprivation therapy of prostate cancer.
- Disorders known to affect vitamin D metabolism such as sarcoidosis or renal failure or malabsorption disorders (e.g. pancreatic insufficiency or celiac disease).
- Regular (monthly or more frequent) use of tanning salons.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Double-blind Study Investigating Dose-dependent Longitudinal Effects of Vitamin D Supplementation on Bone Health
We propose to conduct a randomized double blind trial of three doses of vitamin D, 400, 4000, and 10,000 International Units (IU) per day, to assess the effect on bone density and architecture as assessed by high resolution peripheral quantitative tomography (HR-pQCT) measurements at the radius and distal tibia, and standard Dual X-ray absorptiometry (DXA). Other measures of bone and calcium metabolism will be assessed. The trial will last as long as three years. Approximately 300 healthy men and women, aged 50-70 years of age, will be recruited, and randomly assigned to one of the three doses of vitamin D. Other outcome variables assessed include quality of life, depression, muscle strength and balance.
Read the detailed description
Hypotheses being tested:
- It is hypothesized that vitamin D, in a dose-dependent manner, will suppress parathyroid hormone action, resulting in less bone turnover, and decreased cortical porosity, leading to improved bone strength as assessed by finite element analysis.
- It is hypothesized that vitamin D, in a dose-dependent manner, will increase bone density in the central skeleton (spine, hip), as measured by the current standard method of dual X-ray absorptiometry (DXA).
- It is hypothesized that vitamin D, in a dose-dependent manner, will have an impact on quality of life, including indices of depression, as measured by the SF-36 questionnaire and an appropriate index of depression.
Outcomes:
Primary outcomes:
- (1) bone density and (2) strength as measured by HR-pQCT
Secondary outcomes:
- HR-pQCT assessment of bone microarchitecture, examining the relative contribution of trabecular and cortical bone. We have chosen four parameters for statistical analysis, and have listed them as secondary outcome variables in the section below: cortical density, cortical porosity, trabecular density and trabecular number.
- bone mineral density as measured by DXA
- parameters of calcium metabolism, including biochemical markers of bone turnover and DNA to examine possible variations in the genes that control vitamin D metabolism.
- quality of life score
- depression scale score
- balance, grip strength.
- fasting glucose and Hemoglobin A1C will also be measured.
- Safety will be assessed during the scheduled follow-up visits by obtaining history of adverse events, as well as measurements of serum and urine parameters of mineral metabolism as described below.
INTERVENTION DRUG: Vitamin D3 in one of three doses Rationale: For adults under age 70 years, the recent Institute of Medicine (IOM) report recommends a total intake of 600 IU vitamin D/day will provide all the vitamin D needed for bone health, and since the typical Canadian diet contains between 200 and 300 units of vitamin D, the subjects in the lowest dose arm of our study will receive 400 IU/day. The other two groups will receive 10,000 IU and 4,000 IU, respectively. The 10,000 IU dose is the tolerable upper intake level (TUL) recommended by Hathcock et al (Am J Clin Nutr 2007) and 4,000 IU is the IOM's recommended TUL.
Calcium intake:
All subjects will have adequate calcium intake as defined by the Institute of Medicine (total of 1200 mg/day). A brief dietary history will be taken and subjects will be instructed to take an appropriate dose of supplemental calcium if their daily intake is less than 1200 mg/day (the IOM's Recommended Daily Allowance for this study population).
Interim analysis (with maintenance of blinding of subjects and investigators as to treatment arm):
- planned at and of years 1 and 2, as well as the final analysis at year 3.
- Conditions
- Age-Related Osteoporosis
- Being tested
- Vitamin D
- Keywords
- Vitamin D, Bone quality, Bone density, calcium metabolism, High resolution peripheral quantitative computed tomography, Dual X-ray absorptiometry, Quality of life
- Medical subject headings
- Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin DDietary supplement
Also called Vitamin D3, Cholecalciferol
Three different doses of vitamin D will be administered in a double-blinded fashion. The three doses are 400, 4000, or 10,000 IU/day
| Study group | Role | What they receive |
|---|---|---|
| vitamin D 10,000 IU | Active comparator | Subjects in this arm receive 10,000 IU Vitamin D p.o. (as 5 drops of a blinded vitamin D solution) per day. Duration: 3 years Receives: Dietary Supplement: Vitamin D |
| Vitamin D 4000 IU | Active comparator | Subjects in this arm receive 4,000 IU Vitamin D p.o. (as 5 drops of a blinded vitamin D solution) per day. Duration: 3 years Receives: Dietary Supplement: Vitamin D |
| Vitamin D 400 IU | Active comparator | Subjects in this arm receive 400 IU Vitamin D p.o. (as 5 drops of a blinded vitamin D solution) per day. Duration: 3 years Receives: Dietary Supplement: Vitamin D |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Bone Mineral Density (Tt.BMD) at the distal radius and tibia, as measured by High Resolution peripheral Quantitative Tomography (HR-pQCT)
Unlike the measurement of bone density by DXA (a secondary outcome, see below), which estimates bone density based on assumptions of the depth of a 2-dimensional image of bone, HR-pQCT measurement of Tt.BMD provides a true volume based density measurement. HR-pQCT also provides a much higher resolution image of the region of interest than the image derived from a DXA measurement.
Units of this measurement are milligrams hydroxyapatite per cubic centimetre (mg HA/cm3).
The analysis will examine change in Tt.BMD at distal radius and tibia from baseline to measurements at 6, 12, 24, and 36 months.
Measured: Participants will be followed from baseline up to 36 months
Bone strength, as estimated by Finite Element Analysis of High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) measurements at the distal radius and tibia
HR-pQCT scans provide the ability to measure a true volumetric density of the bone region of interest and to study microarchitecture of both trabecular and cortical bone, from which an assessment of strength by Finite Element Analysis (FEA) can be determined: briefly, a 3-dimensional computer model of bone can be constructed from the HR-pQCT data, and subjected to strength testing. FEA software (FAIM, version 6.0, Numerics88 Solutions, Calgary, Canada) is used to estimate failure load (N) based on 2 % of the elements exceeding 7,000 μstrain.
The analysis examines change from baseline measured at 6, 12, 24, and 36 months.
Measured: Participants will be followed from baseline up to 36 months
Secondary outcomes (9)
Cortical bone density (Ct.BMD) of bone as measured by HR-pQCT
Cortical density (Ct.BMD) is a morphological parameter of microarchitecture of bone, and is measured in mg HA/cm3
Measured: From baseline to 36 months - measured at 0, 6, 12, 24, and 36 months.
Cortical Porosity (Ct.Po) of bone as measured by HR-pQCT
Cortical Porosityis a morphological parameter of microarchitecture of bone, and is measured in percent.
Measured: From baseline to 36 months - measured at 0, 6, 12, 24, and 36 months.
Trabecular bone density (Tb.BMD) of bone as measured by HR-pQCT
Trabecular density (Tb.BMD) is a morphological parameter of microarchitecture of bone, and is measured in mg HA/cm3
Trabecular density (Tb.BMD) is a morphological parameter of microarchitecture of bone, and is measured in mg HA/cm3
Measured: From baseline to 36 months - measured at 0, 6, 12, 24, and 36 months.
Trabecular number (Tb.N) as measured by HR-pQCT
Trabecular number (Tb.N) is a morphological parameter of microarchitecture of bone, and is measured as mean number of trabeculae per unit of length (mm)
Measured: From baseline to 36 months - measured at 0, 6, 12, 24, and 36 months.
Bone Mineral Density as measured by Dual X-ray Absorptiometry
Dual X-ray absorptiometry (DXA) will be used to scan the distal radius, lumbar spine and the proximal femur to obtain an areal (two dimensional) estimate of bone mineral density (aBMD). DXA is the current clinical standard for measuring bone density. From the scan of the lumbar spine and left proximal femur (~ 1 min), aBMD (g/cm2) will be used to determine a subject-specific T-score (aBMD compared to reference mean for a young healthy adult) and this value will be compared to standard World Health Organization criteria to classify each subject as normal (T-score>-1), low bone density (-1 < T > -2.5) or osteoporotic (T score < -2.5). Change from baseline will be assessed at 12, 24 and 36 months.
Measured: Participants will be followed from baseline up to 36 months
Quality of Life (Mental Health Component)
Vitamin D deficiency has been associated with depression. We propose to examine whether our Vitamin D intervention has an effect on depression or other aspects of mental health. The SF-36 questionnaire will be administered at baseline and at 12, 24, and 36 months. This will be used to assess subjects' perception of their Quality of Life, specifically the Mental Health Component, and whether the intervention (Vitamin D dose assignment) is associated with changes in the SF-36 scores for Mental Health Component change over the course of the study.
Measured: Participants will be followed from baseline up to 36 months
Depression symptoms
PHQ-9 questionnaire will be used to assess any effect the Vitamin D intervention might have on depression symptoms. The PHQ-9 analog scale score will be measured at entry and at 3, 6 and 12 months, then annually. This is not expected to be a safety issue in recruiting healthy volunteers, but obviously could become one.
Measured: Participants will be followed from baseline up to 36 months
Biochemical markers of calcium and bone metabolism
In addition to the markers identified as safety measures in "other outcomes" (serum and urine calcium, serum creatinine, etc), we will also obtain serum for measurement of markers of bone turnover: serum C-telopeptide of Type I Collagen (CTX), and Procollagen I N-terminal Propeptide. Measurements taken at baseline and at 3, 6, 12, 24, and 36 months. Still to be arranged: Under-carboxylated osteocalcin and osteocalcin.
Measured: Participants will be followed from baseline up to 36 months
Balance and grip strength
The balance tests include standing with (a) two feet on the force platform with eyes open, (b) two feet on the force platform with eyes closed, (c) two feet on a foam pad with eyes open, and (d) two feet on a foam pad with eyes closed. All tests will be performed 3 times, and a blindfold will be used for all eyes-closed assessments. The total testing time is approximately 15 minutes. Measurements done at baseline and at 12, 24 and 36 months
Measured: Participants will be followed from baseline up to 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2013 (estimated)
- Study startAug 2013
- Primary completion7 Dec 2017
- Study completion31 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Age-Related OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of CalgaryThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 311 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Calgary
- Sponsor type
- University, hospital or other
- Collaborators
- Pure North S'Energy Foundation
- Responsible party
- Principal investigator, David A. Hanley, MD, FRCPC, University of Calgary
- Investigators
- David A Hanley, MD, FRCPC, Principal investigator, The University of CalgarySteven K Boyd, PhD, Principal investigator, The University of Calgary
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01900860
- Sponsor's protocol ID
- 20130101
- Status last verified
- Apr 2019
- First submitted
- 2 Jul 2013
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Burt LA, Gaudet S, Kan M, Rose MS, Billington EO, Boyd SK, Hanley DA. Methods and procedures for: A randomized double-blind study investigating dose-dependent longitudinal effects of vitamin D supplementation on bone health. Contemp Clin Trials. 2018 Apr;67:68-73. doi: 10.1016/j.cct.2018.02.009. Epub 2018 Feb 20.
PubMed 29471124Burt LA, Billington EO, Rose MS, Kremer R, Hanley DA, Boyd SK. Adverse Effects of High-Dose Vitamin D Supplementation on Volumetric Bone Density Are Greater in Females than Males. J Bone Miner Res. 2020 Dec;35(12):2404-2414. doi: 10.1002/jbmr.4152. Epub 2020 Sep 16.
PubMed 32777104Billington EO, Burt LA, Plett R, Rose MS, Boyd SK, Hanley DA. Effect of high-dose vitamin D supplementation on peripheral arterial calcification: secondary analysis of a randomized controlled trial. Osteoporos Int. 2020 Nov;31(11):2141-2150. doi: 10.1007/s00198-020-05500-2. Epub 2020 Jun 15.
PubMed 32556518Billington EO, Burt LA, Rose MS, Davison EM, Gaudet S, Kan M, Boyd SK, Hanley DA. Safety of High-Dose Vitamin D Supplementation: Secondary Analysis of a Randomized Controlled Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz212. doi: 10.1210/clinem/dgz212.
PubMed 31746327Burt LA, Billington EO, Rose MS, Raymond DA, Hanley DA, Boyd SK. Effect of High-Dose Vitamin D Supplementation on Volumetric Bone Density and Bone Strength: A Randomized Clinical Trial. JAMA. 2019 Aug 27;322(8):736-745. doi: 10.1001/jama.2019.11889.
PubMed 31454046
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Study Investigating Dose-dependent Longitudinal Effects of Vitamin D Supplementation on Bone Health
- ClinicalTrials.gov ID
- NCT01900860
- Acronym / sponsor ID
- 20130101
- Conditions
- Age-Related Osteoporosis
- Keywords
- Vitamin D, Bone quality, Bone density, calcium metabolism, High resolution peripheral quantitative computed tomography, Dual X-ray absorptiometry, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 311 participants (actual)
- Lead sponsor
- University of CalgaryUniversity, hospital or other
- Collaborators
- Pure North S'Energy Foundation
- Study start
- Aug 2013
- Primary completion
- 7 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 17 Jul 2013 (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.
We propose to conduct a randomized double blind trial of three doses of vitamin D, 400, 4000, and 10,000 International Units (IU) per day, to assess the effect on bone density and architecture as assessed by high resolution peripheral quantitative tomography (HR-pQCT) measurements at the radius and distal tibia, and standard Dual X-ray absorptiometry (DXA). Other measures of bone and calcium metabolism will be assessed. The trial will last as long as three years. Approximately 300 healthy men and women, aged 50-70 years of age, will be recruited, and randomly assigned to one of the three doses of vitamin D. Other outcome variables assessed include quality of life, depression, muscle strength and balance.
Detailed description
Hypotheses being tested:
- It is hypothesized that vitamin D, in a dose-dependent manner, will suppress parathyroid hormone action, resulting in less bone turnover, and decreased cortical porosity, leading to improved bone strength as assessed by finite element analysis.
- It is hypothesized that vitamin D, in a dose-dependent manner, will increase bone density in the central skeleton (spine, hip), as measured by the current standard method of dual X-ray absorptiometry (DXA).
- It is hypothesized that vitamin D, in a dose-dependent manner, will have an impact on quality of life, including indices of depression, as measured by the SF-36 questionnaire and an appropriate index of depression.
Outcomes:
Primary outcomes:
- (1) bone density and (2) strength as measured by HR-pQCT
Secondary outcomes:
- HR-pQCT assessment of bone microarchitecture, examining the relative contribution of trabecular and cortical bone. We have chosen four parameters for statistical analysis, and have listed them as secondary outcome variables in the section below: cortical density, cortical porosity, trabecular density and trabecular number.
- bone mineral density as measured by DXA
- parameters of calcium metabolism, including biochemical markers of bone turnover and DNA to examine possible variations in the genes that control vitamin D metabolism.
- quality of life score
- depression scale score
- balance, grip strength.
- fasting glucose and Hemoglobin A1C will also be measured.
- Safety will be assessed during the scheduled follow-up visits by obtaining history of adverse events, as well as measurements of serum and urine parameters of mineral metabolism as described below.
INTERVENTION DRUG: Vitamin D3 in one of three doses Rationale: For adults under age 70 years, the recent Institute of Medicine (IOM) report recommends a total intake of 600 IU vitamin D/day will provide all the vitamin D needed for bone health, and since the typical Canadian diet contains between 200 and 300 units of vitamin D, the subjects in the lowest dose arm of our study will receive 400 IU/day. The other two groups will receive 10,000 IU and 4,000 IU, respectively. The 10,000 IU dose is the tolerable upper intake level (TUL) recommended by Hathcock et al (Am J Clin Nutr 2007) and 4,000 IU is the IOM's recommended TUL.
Calcium intake:
All subjects will have adequate calcium intake as defined by the Institute of Medicine (total of 1200 mg/day). A brief dietary history will be taken and subjects will be instructed to take an appropriate dose of supplemental calcium if their daily intake is less than 1200 mg/day (the IOM's Recommended Daily Allowance for this study population).
Interim analysis (with maintenance of blinding of subjects and investigators as to treatment arm):
- planned at and of years 1 and 2, as well as the final analysis at year 3.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| vitamin D 10,000 IU | Active comparator | Dietary Supplement: Vitamin DSubjects in this arm receive 10,000 IU Vitamin D p.o. (as 5 drops of a blinded vitamin D solution) per day. Duration: 3 years |
| Vitamin D 4000 IU | Active comparator | Dietary Supplement: Vitamin DSubjects in this arm receive 4,000 IU Vitamin D p.o. (as 5 drops of a blinded vitamin D solution) per day. Duration: 3 years |
| Vitamin D 400 IU | Active comparator | Dietary Supplement: Vitamin DSubjects in this arm receive 400 IU Vitamin D p.o. (as 5 drops of a blinded vitamin D solution) per day. Duration: 3 years |
Who may qualify
- Ages
- 55 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Healthy women and men between 55 and 70 years of age; women will be at least 5 years post-menopause. Presence of a chronic illness does not exclude participation if the condition is stable and managed by a physician.
- Baseline lumbar spine and total hip bone mineral density (BMD) T-score above 2.5 as assessed using dual x-ray absorptiometry (DXA).
Key exclusion criteria (14 listed)
- A serum 25-[OH] vitamin D (25OHD) of <30 nmol/L (<12 ng/mL) or >125 nmol/L (50 ng/mL).
- Hypercalcemia (serum calcium >2.55 mmol/L), hypocalcemia (serum calcium <2.10 mmol/L) or eGFR <30 mL/min.
- Surgical cure of Primary Hyperparathyroidism within the last year.
- Active kidney stone disease (recurrent stones, recent kidney stone [within last 2 years])
- Known hypersensitivity or allergy to Vitamin D
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 |
|---|---|---|
| Vitamin DAlso: Vitamin D3, CholecalciferolThree different doses of vitamin D will be administered in a double-blinded fashion. The three doses are 400, 4000, or 10,000 IU/day | Dietary supplement | Vitamin D 400 IU, Vitamin D 4000 IU, vitamin D 10,000 IU |
Primary outcome
Total Bone Mineral Density (Tt.BMD) at the distal radius and tibia, as measured by High Resolution peripheral Quantitative Tomography (HR-pQCT)
Time frame: Participants will be followed from baseline up to 36 months
Unlike the measurement of bone density by DXA (a secondary outcome, see below), which estimates bone density based on assumptions of the depth of a 2-dimensional image of bone, HR-pQCT measurement of Tt.BMD provides a true volume based density measurement. HR-pQCT also provides a much higher resolution image of the region of interest than the image derived from a DXA measurement. Units of this measurement are milligrams hydroxyapatite per cubic centimetre (mg HA/cm3). The analysis will examine change in Tt.BMD at distal radius and tibia from baseline to measurements at 6, 12, 24, and 36 months.
Bone strength, as estimated by Finite Element Analysis of High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) measurements at the distal radius and tibia
Time frame: Participants will be followed from baseline up to 36 months
HR-pQCT scans provide the ability to measure a true volumetric density of the bone region of interest and to study microarchitecture of both trabecular and cortical bone, from which an assessment of strength by Finite Element Analysis (FEA) can be determined: briefly, a 3-dimensional computer model of bone can be constructed from the HR-pQCT data, and subjected to strength testing. FEA software (FAIM, version 6.0, Numerics88 Solutions, Calgary, Canada) is used to estimate failure load (N) based on 2 % of the elements exceeding 7,000 μstrain. The analysis examines change from baseline measured at 6, 12, 24, and 36 months.
9 secondary outcomes
Cortical bone density (Ct.BMD) of bone as measured by HR-pQCT
Time frame: From baseline to 36 months - measured at 0, 6, 12, 24, and 36 months.
Cortical Porosity (Ct.Po) of bone as measured by HR-pQCT
Time frame: From baseline to 36 months - measured at 0, 6, 12, 24, and 36 months.
Trabecular bone density (Tb.BMD) of bone as measured by HR-pQCT
Time frame: From baseline to 36 months - measured at 0, 6, 12, 24, and 36 months.
Trabecular number (Tb.N) as measured by HR-pQCT
Time frame: From baseline to 36 months - measured at 0, 6, 12, 24, and 36 months.
Bone Mineral Density as measured by Dual X-ray Absorptiometry
Time frame: Participants will be followed from baseline up to 36 months
Quality of Life (Mental Health Component)
Time frame: Participants will be followed from baseline up to 36 months
Depression symptoms
Time frame: Participants will be followed from baseline up to 36 months
Biochemical markers of calcium and bone metabolism
Time frame: Participants will be followed from baseline up to 36 months
Balance and grip strength
Time frame: Participants will be followed from baseline up to 36 months
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 17 Apr 2019.
- Background: PubMed 29471124Burt LA, Gaudet S, Kan M, Rose MS, Billington EO, Boyd SK, Hanley DA. Methods and procedures for: A randomized double-blind study investigating dose-dependent longitudinal effects of vitamin D supplementation on bone health. Contemp Clin Trials. 2018 Apr;67:68-73. doi: 10.1016/j.cct.2018.02.009. Epub 2018 Feb 20.
- Derived from this study: PubMed 32777104Burt LA, Billington EO, Rose MS, Kremer R, Hanley DA, Boyd SK. Adverse Effects of High-Dose Vitamin D Supplementation on Volumetric Bone Density Are Greater in Females than Males. J Bone Miner Res. 2020 Dec;35(12):2404-2414. doi: 10.1002/jbmr.4152. Epub 2020 Sep 16.
- Derived from this study: PubMed 32556518Billington EO, Burt LA, Plett R, Rose MS, Boyd SK, Hanley DA. Effect of high-dose vitamin D supplementation on peripheral arterial calcification: secondary analysis of a randomized controlled trial. Osteoporos Int. 2020 Nov;31(11):2141-2150. doi: 10.1007/s00198-020-05500-2. Epub 2020 Jun 15.
- Derived from this study: PubMed 31746327Billington EO, Burt LA, Rose MS, Davison EM, Gaudet S, Kan M, Boyd SK, Hanley DA. Safety of High-Dose Vitamin D Supplementation: Secondary Analysis of a Randomized Controlled Trial. J Clin Endocrinol Metab. 2020 Apr 1;105(4):dgz212. doi: 10.1210/clinem/dgz212.
- Derived from this study: PubMed 31454046Burt LA, Billington EO, Rose MS, Raymond DA, Hanley DA, Boyd SK. Effect of High-Dose Vitamin D Supplementation on Volumetric Bone Density and Bone Strength: A Randomized Clinical Trial. JAMA. 2019 Aug 27;322(8):736-745. doi: 10.1001/jama.2019.11889.
- Individual participant dataSharing planned: Undecided
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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.
David A Hanley, MD, FRCPC principal investigator
The University of Calgary
Steven K Boyd, PhD principal investigator
The University of Calgary
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vitamin D in people with Age-Related Osteoporosis, run by University of Calgary at 1 site in Canada.
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 2 inclusion and 14 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 17 Apr 2019. 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 Canada. 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. 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?
Total Bone Mineral Density (Tt.BMD) at the distal radius and tibia, as measured by High Resolution peripheral Quantitative Tomography (HR-pQCT) (time frame: Participants will be followed from baseline up to 36 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01900860, which also lists 5 linked publications.
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 17 Apr 2019.