OsteoporosisPhase 4AldOstNCT02572960
Physiologic Interactions Between the Adrenal- and the Parathyroid Glands
A Phase 4 study testing Valsartan and Cholecalciferol in people with Osteoporosis and Vitamin D Deficiency, run by University of Aarhus at 1 site in Denmark.
Trial summary
To investigate possible physiologic interactions between the adrenal- and the parathyroid glands in patients with secondary hyperparathyroidism. Read more about this study
- Who is it for?
- Ages 60 to 80 years, women only
- Conditions the study is for
- Osteoporosis, Vitamin D Deficiency, Cardiovascular Disease
- What is being tested?
- Valsartan and Cholecalciferol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2015to May 2017
- Phase
- Phase 4
- 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 60 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Secondary hyperparathyroidism due to Vitamin D deficiency
Who cannot join
- Cardiovascular disease
- Renal failure
- Liver failure
- Treatment with antihypertensive medication or diuretics
- Treatment with lithium, NSAID or glucocorticoids
- Calcium supplement more than 500 mg per day or Vitamin D supplement more than 25 microgram per day
Show all 11Show fewer
- Medical treatment for osteoporosis
- Systolic blood pressure below 120 mmHg
- Hypercalcaemia (more than 1,33mmol/L)
- Use of solarium or planned trip to countries, that might increase the endogenous vitamin D synthesis
- Allergic reaction to ACEi or ARBs.
Trial locations and contacts
1 site in 1 country.
About this study
To investigate possible physiologic interactions between the adrenal- and the parathyroid glands in patients with secondary hyperparathyroidism.
Read the detailed description
In primary hyperparathyroidism, chronic-elevated PTH levels seem to stimulate the renin-angiotensin-aldosterone system (RAAS) which may explain the increased risk of cardiovascular disease. In addition to increased PTH levels, vitamin D has been shown to inhibit the RAAS. However, a possible physiologic interaction needs further investigation.
The purpose of the study is to investigate changes in the RAAS in otherwise healthy postmenopausal women with secondary hyperparathyroidism due to vitamin D deficiency when p-PTH is normalized.
Furthermore, we will evaluate whether an angiotensin 2 receptor blocker can lower PTH in patients with secondary hyperparathyroidism.
- Conditions
- Osteoporosis, Vitamin D Deficiency, Cardiovascular Disease
- Being tested
- Valsartan, Placebo Valsartan, Cholecalciferol, Placebo cholecalciferol
- Medical subject headings
- Osteoporosis, Vitamin D Deficiency, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValsartanDrug
2 weeks of Valsartan 80 mg per day
Placebo ValsartanDrug
2 weeks of Placebo Valsartan, one tablet per day. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.
CholecalciferolDietary supplement
Also called Vitamin D3
12 weeks of daily cholecalciferol treatment, 70 microgram per day
Placebo cholecalciferolDietary supplement
Also called Placebo D3
12 weeks of daily Placebo cholecalciferol treatment. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet.
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Placebo comparator | Cholecalciferol 70 mcg/day for 12 weeks Placebo Valsartan daily for 2 weeks Receives: Dietary Supplement: Cholecalciferol |
| Valsartan | Active comparator | Placebo cholecalciferol/day for 12 weeks Valsartan 80 mg/day for 2 weeks Receives: Drug: Valsartan |
| Placebo | Placebo comparator | Placebo cholecalciferol/day for 12 weeks Placebo Valsartan daily for 2 weeks Receives: Drug: Placebo Valsartan; Dietary Supplement: Placebo cholecalciferol |
| Cholecalciferol and Valsartan | Active comparator | Cholecalciferol 70 mcg/day for 12 weeks Valsartan 80 mg/day for 2 weeks Receives: Drug: Valsartan; Dietary Supplement: Cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aldosterone, before and after 12 weeks of daily cholecalciferol treatment
Measured: Change from baseline p-aldosterone at 12 weeks
Secondary outcomes (15)
Parathyroid hormone, before and after, daily ARB administrations
Measured: Change from baseline p-PTH at 2 weeks
Arterial stiffness
Spygmocor
Measured: Change from baseline arterial stiffness at 12 weeks
24 hours arterial stiffness as measured by tonometry
Arteriograph 24
Measured: Change from baseline arterial stiffness PWV at 12 weeks
24 hours blood pressure measured by tonometry
Arteriograph 24
Measured: Change from baseline systolic pressure at 12 weeks
Balance as measured by stadiometer (Meitur Ltd)
Postural stability
Measured: Change from postural balance at 12 weeks
Muscle strength as measured by isometric tests
Effects on muscle strength (isometric tests of flexion and extension of thigh and hand), two function-tests (timed up-and go and timed stand-and-sit),
Measured: Change from baseline isometric muscle strength at 12 weeks
Bone density and geometry as measured by QCT scans
Bone quality in spine and hip as assessed by high resolution quantitative computed tomography HRQCT-scans
Measured: Change from baseline at 12 weeks
Bone density and geometry as measured by HRpQCT scans
Bone quality in ankle and forearm as assessed by high resolution peripheral quantitative computed tomography HRpQCT-scans
Measured: Change from baseline at 12 weeks
Bone density by DXA
Bone density assessed by dual energy x-ray absorptiometry (DXA)
Measured: Change from baseline at 12 weeks
Electrocardiogram
Hearth rhythm, shortened QT interval, hypertrophy
Measured: Change from baseline at 2, 6 and 12 weeks
Biomarkers of calcium- and bone metabolism
Effects of intervention on biochemical markers of calcium and bone metabolism, such as calcium, phosphate, parathyroid hormone, calcitriol, vitamin D-binding protein, bone-specific alkaline phosphatase, osteocalcin, and N-terminal propeptide of type 1 procollagen (P1NP). Also C-terminal telopeptide of type 1 collagen (CTX) and N-telopeptide of type 1 collagen (NTX) among others.
Measured: Change from baseline at 2, 6 and 12 weeks
Quality of Life, SF36
SF36v2
Measured: Change from baseline at 12 weeks
Quality of Life, WHO-5
WHO-5 well being index
Measured: Change from baseline at 12 weeks
Physical activity
Physical activity scale
Measured: Change from baseline at 12 weeks
Hyperparathyroid symptoms
Pasieka's parathyroid symptoms score
Measured: Change from baseline at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for OsteoporosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lars Rejnmark, Professor, Principal investigator, Department of Endocrinology and Internal medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02572960
- Sponsor's protocol ID
- 2014-LSB
- Acronym
- AldOst
- Status last verified
- May 2016
- First submitted
- 7 Oct 2015
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.
PubMed 35018442Bislev LS, Langagergaard Rodbro L, Rolighed L, Sikjaer T, Rejnmark L. Bone Microstructure in Response to Vitamin D3 Supplementation: A Randomized Placebo-Controlled Trial. Calcif Tissue Int. 2019 Feb;104(2):160-170. doi: 10.1007/s00223-018-0481-6. Epub 2018 Oct 6.
PubMed 30293198Bislev LS, Langagergaard Rodbro L, Rolighed L, Sikjaer T, Rejnmark L. Effects of Vitamin D3 Supplementation on Muscle Strength, Mass, and Physical Performance in Women with Vitamin D Insufficiency: A Randomized Placebo-Controlled Trial. Calcif Tissue Int. 2018 Nov;103(5):483-493. doi: 10.1007/s00223-018-0443-z. Epub 2018 Jun 21.
PubMed 29931459
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiologic Interactions Between the Adrenal- and the Parathyroid Glands
- ClinicalTrials.gov ID
- NCT02572960
- Acronym / sponsor ID
- AldOst / 2014-LSB
- Conditions
- Osteoporosis, Vitamin D Deficiency, Cardiovascular Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 9 Oct 2015 (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.
To investigate possible physiologic interactions between the adrenal- and the parathyroid glands in patients with secondary hyperparathyroidism.
Detailed description
In primary hyperparathyroidism, chronic-elevated PTH levels seem to stimulate the renin-angiotensin-aldosterone system (RAAS) which may explain the increased risk of cardiovascular disease. In addition to increased PTH levels, vitamin D has been shown to inhibit the RAAS. However, a possible physiologic interaction needs further investigation.
The purpose of the study is to investigate changes in the RAAS in otherwise healthy postmenopausal women with secondary hyperparathyroidism due to vitamin D deficiency when p-PTH is normalized.
Furthermore, we will evaluate whether an angiotensin 2 receptor blocker can lower PTH in patients with secondary hyperparathyroidism.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol | Placebo comparator | Dietary Supplement: CholecalciferolCholecalciferol 70 mcg/day for 12 weeks Placebo Valsartan daily for 2 weeks |
| Valsartan | Active comparator | Drug: ValsartanPlacebo cholecalciferol/day for 12 weeks Valsartan 80 mg/day for 2 weeks |
| Placebo | Placebo comparator | Drug: Placebo Valsartan, Dietary Supplement: Placebo cholecalciferolPlacebo cholecalciferol/day for 12 weeks Placebo Valsartan daily for 2 weeks |
| Cholecalciferol and Valsartan | Active comparator | Drug: Valsartan, Dietary Supplement: CholecalciferolCholecalciferol 70 mcg/day for 12 weeks Valsartan 80 mg/day for 2 weeks |
Who may qualify
- Ages
- 60 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Secondary hyperparathyroidism due to Vitamin D deficiency
Key exclusion criteria (11 listed)
- Cardiovascular disease
- Renal failure
- Liver failure
- Treatment with antihypertensive medication or diuretics
- Treatment with lithium, NSAID or glucocorticoids
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 |
|---|---|---|
| Valsartan2 weeks of Valsartan 80 mg per day | Drug | Cholecalciferol and Valsartan, Valsartan |
| Placebo Valsartan2 weeks of Placebo Valsartan, one tablet per day. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet. | Drug | Placebo |
| CholecalciferolAlso: Vitamin D312 weeks of daily cholecalciferol treatment, 70 microgram per day | Dietary supplement | Cholecalciferol, Cholecalciferol and Valsartan |
| Placebo cholecalciferolAlso: Placebo D312 weeks of daily Placebo cholecalciferol treatment. Placebo tablets are identical in regards to size and appearance to the experimental intervention tablet. | Dietary supplement | Placebo |
Primary outcome
Aldosterone, before and after 12 weeks of daily cholecalciferol treatment
Time frame: Change from baseline p-aldosterone at 12 weeks
15 secondary outcomes
Parathyroid hormone, before and after, daily ARB administrations
Time frame: Change from baseline p-PTH at 2 weeks
Arterial stiffness
Time frame: Change from baseline arterial stiffness at 12 weeks
24 hours arterial stiffness as measured by tonometry
Time frame: Change from baseline arterial stiffness PWV at 12 weeks
24 hours blood pressure measured by tonometry
Time frame: Change from baseline systolic pressure at 12 weeks
Balance as measured by stadiometer (Meitur Ltd)
Time frame: Change from postural balance at 12 weeks
Muscle strength as measured by isometric tests
Time frame: Change from baseline isometric muscle strength at 12 weeks
Bone density and geometry as measured by QCT scans
Time frame: Change from baseline at 12 weeks
Bone density and geometry as measured by HRpQCT scans
Time frame: Change from baseline at 12 weeks
Bone density by DXA
Time frame: Change from baseline at 12 weeks
Electrocardiogram
Time frame: Change from baseline at 2, 6 and 12 weeks
Biomarkers of calcium- and bone metabolism
Time frame: Change from baseline at 2, 6 and 12 weeks
Quality of Life, SF36
Time frame: Change from baseline at 12 weeks
Quality of Life, WHO-5
Time frame: Change from baseline at 12 weeks
Physical activity
Time frame: Change from baseline at 12 weeks
Hyperparathyroid symptoms
Time frame: Change from baseline at 12 weeks
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 15 Aug 2018.
- Derived from this study: PubMed 35018442Bislev LS, Wamberg L, Rolighed L, Grove-Laugesen D, Rejnmark L. Effect of Daily Vitamin D3 Supplementation on Muscle Health: An Individual Participant Meta-analysis. J Clin Endocrinol Metab. 2022 Apr 19;107(5):1317-1327. doi: 10.1210/clinem/dgac004.
- Derived from this study: PubMed 30293198Bislev LS, Langagergaard Rodbro L, Rolighed L, Sikjaer T, Rejnmark L. Bone Microstructure in Response to Vitamin D3 Supplementation: A Randomized Placebo-Controlled Trial. Calcif Tissue Int. 2019 Feb;104(2):160-170. doi: 10.1007/s00223-018-0481-6. Epub 2018 Oct 6.
- Derived from this study: PubMed 29931459Bislev LS, Langagergaard Rodbro L, Rolighed L, Sikjaer T, Rejnmark L. Effects of Vitamin D3 Supplementation on Muscle Strength, Mass, and Physical Performance in Women with Vitamin D Insufficiency: A Randomized Placebo-Controlled Trial. Calcif Tissue Int. 2018 Nov;103(5):483-493. doi: 10.1007/s00223-018-0443-z. Epub 2018 Jun 21.
- Individual participant dataSharing planned: No
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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.
Lars Rejnmark, Professor principal investigator
Department of Endocrinology and Internal medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valsartan and Cholecalciferol in people with Osteoporosis and Vitamin D Deficiency, run by University of Aarhus at 1 site in Denmark.
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 1 inclusion and 11 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 15 Aug 2018. 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 Denmark. 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 phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 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?
Aldosterone, before and after 12 weeks of daily cholecalciferol treatment (time frame: Change from baseline p-aldosterone at 12 weeks). 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 NCT02572960, which also lists 3 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 15 Aug 2018.