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Osteopenia/OsteoporosisPhase 2NCT02527668

To Test the Effect of Calcifediol Hy.D Supplementation on Muscle Function and Bone Quality in Younger Postmenopausal Women With Osteopenia

A Phase 2 study testing Calcifediol and Vitamin D3 in people with Osteopenia/Osteoporosis, run by dsm-firmenich Switzerland AG at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Young postmenopausal women with osteopenia / or women with osteoporosis and a FRAX score below pharmacologic treatment indication have limited treatment options in the prevention of osteoporosis/treatment of osteopenia. Read more about this study

Who is it for?
Ages 50 to 70 years, women onlyHealthy volunteers can take part
Conditions the study is for
Osteopenia/Osteoporosis
What is being tested?
Calcifediol and Vitamin D3
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
150 participants
Where
1 siteSwitzerland
Study dates
Sep 2015to Dec 2018
Phase
Phase 2
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 50 to 70 years
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Women age 50 to 70
  • Post-menopausal (defined as: at least 1 year after the last menstrual period)
  • community-dwelling and ambulatory without help
  • with documented osteopenia (BMD by DEXA t-score: < -1.0 and > -2.5 at the spine or hip) in the 6 months prior to enrolment or with documented osteoporosis (BMD by DEXA t-score: ≤ -2.5 at the spine or hip) and a FRAX score (online calculation tool of absolute 10 year fracture risk) below the Swiss age-dependent indication threshold for pharmacologic treatment for the 10-year risk of major osteoporotic fractures - at the screening visit and including DEXA (in the 6 months prior to enrolment) as part of the calculation
  • body mass index > 18.5 and < 30 kg/m2
  • 25(OH)D level < 24 µg/l (< 60 nmol/l)
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  • understands German in reading and writing plus able to read, understand, and complete questionnaires and tests
  • willingness to limit additional vitamin D3 intake to 800 IU per day
  • willingness to limit calcium supplement intake to 500 mg/day
  • willingness to stop active vitamin D metabolites
  • participant understands the study procedures, alternative treatments available and risks involved with the study and voluntarily agrees to participate by giving a written informed consent
  • participant meets the routine clinical laboratory safety screening tests performed at screening visit
  • participant is able and willing to perform all study tests, attend all required office visits, and provide blood and urine samples
  • participant is able to swallow the study medication

Who cannot join

  • Consumption of more than 1'000 IU vitamin D on any day in the 4 weeks prior to enrollment.
  • Elevated serum calcium > 2.60 mmol/l adjusted for albumin if albumin ≤ 35 or ≥ 45g/l
  • estimated creatinine clearance < 30 ml/min (Cockcroft and Gault = 140 - age(yr)*weight(kg)/ serum Cr(mmol/l))×(1.04 for women)
  • severe visual or hearing impairment
  • malabsorption syndrome (celiac diseases, inflammatory bowel disease).
  • Pathologic fracture (excl. fractures due to osteoporosis) in the last year
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  • Fracture due to osteoporosis in the last 10 years
  • Chemo therapy / Radiation due to cancer in the last year
  • Treatment which has an effect on calcium metabolism (e.g. PTH, calcitonin, chronic cortisone intake > 5mg/day for more than 4 weeks in the last 12 months (except for inhalation and sporadic infiltration))
  • Current treatment with a bisphosphonate
  • For participants of the ancillary study "Muscle Biopsy" only: Treatment which has an effect on blood coagulation (e.g. factor X inhibitor, thrombin inhibitor, NSAR, low-molecular heparin, inhibitor for platelet aggregation, vitamin K antagonist) and/or abnormal blood coagulation status .
  • Unwilling or unable to take study medication
  • Diseases with a risk of recurrent falling (e.g. Parkinson's disease/syndrome, Hemiplegia after stroke, symptomatic stenosis of the spinal canal, polyneuropathy, epilepsy, recurring vertigo, recurring syncope)
  • History of or current diseases that may enhance serum calcium: sarcoidosis, lymphoma, primary hyperparathyroidism
  • Individual that heavily consumes alcohol containing products defined as greater than (>) 3 drinks (beer, wine, or distilled spirits) of alcoholic beverages per day.
  • Individual is unlikely to adhere to the study procedures, to keep appointments, or is planning to relocate during the study.
  • Individuals who are planning a stay in a "sunny" location (e.g. winter sun resort) for more than one month during the course of the study
  • Medication which has an effect on 25-hydroxyvitamin D level (e.g. certain anticonvulsants (e.g. Phenobarbital, Carbamazepin, Phenytoin))
  • M. Paget (Ostitis deformans)
  • Inflammatory arthritis (e.g. rheumatoid arthritis, Reiter syndrome, psoriasis arthritis)
  • Participation in a study in the last 6 months, except for studies without drug-application, or any influence of the study-medication can be excluded

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Center on Aging and Mobility, Klinik für Geriatrie, UniversitätsSpital Zürich

    Zurich, 8091

Other trials in Switzerland

About this study

Official title: To Test the Effect of Calcifediol Hy.D Supplementation on Muscle Function and Bone Quality in Younger Postmenopausal Women With Osteopenia: a Double-blind Randomized Placebo-controlled Trial

Young postmenopausal women with osteopenia / or women with osteoporosis and a FRAX score below pharmacologic treatment indication have limited treatment options in the prevention of osteoporosis/treatment of osteopenia. Further, there is a concern about long-term side effects of bisphosphonate treatment among young postmenopausal women, and hormone replacement therapy has been controversial. In a pilot study 20 microgram Calcifediol Hy.D improved several muscle related function in this target population within 4 months of treatment, which can help to prevent falls and associated bone fractures. Thus the main aim of this study is to test whether Calcifediol Hy.D at a daily dose of 20 μg / day improves muscle function (lower extremity test battery) compared with (1) placebo and compared with (2) 3200 Vitamin D3 IU per day, at 3 and 6 month follow-up. As a secondary and exploratory objective of this study, the investigators will compare the beforementioned doses on muscle strength and the quality of the bones, beside muscle mass, body composition and systolic and diastolic blood pressure measurements.

Being tested
Calcifediol, Vitamin D3, Placebo
Medical subject headings
Bone Diseases, Metabolic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CalcifediolDietary supplement

    Also called 25-hydroxyvitamin D (Hy.D)

    One capsule orally of Calcifediol (20 µg) per day with a meal for a duration of 6 months

  • Vitamin D3Dietary supplement

    Also called Cholecalciferol

    One capsule orally of Cholecalciferol (3200 IU) per day with a meal for a duration of 6 months

  • PlaceboOther

    One capsule orally of a Placebo capsule per day with a meal for a duration of 6 months

Study groups in NCT02527668
Study groupRoleWhat they receive
Calcifediol Hy.D (25-hydroxyvitamin D)Experimental20 μg Calcifediol Hy.D (25-hydroxyvitamin D) (one capsule) per day for 6 months
Receives: Dietary Supplement: Calcifediol
Vitamin D3 (cholecalciferol)Active comparator3200 IU Vitamin D3 (cholecalciferol) (one capsule) per day for 6 months
Receives: Dietary Supplement: Vitamin D3
PlaceboPlacebo comparator1 Placebo capsule per day for 6 months
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall assessment of the "lower extremity function" test battery (difference in proportion of those who improved or maintained function compared to those who declined in function by treatment group)

    The "lower extremity function" test battery consists of: 8-meter walk test, repeated sit-to-stand test and knee flexion and extension strength test). A repeated measures analysis across all four test battery components simultaneously documenting the difference in proportion of those who improved or maintained function compared to those who declined in function by treatment group (comprised endpoint on lower extremity function) will be performed. Calcifediol Hy.D will be compared with (1) placebo and compared with (2) 3200 Vitamin D3 IU per day -for the time points baseline 3 and 6 months. Outcomes of the individual tests are subject to the secondary outcome measures.

    Measured: Baseline, 3 months, 6 months

Secondary outcomes (5)

  1. Gait speed measurement (8-meter walk)

    Measured: Baseline, 3 months, 6 months

  2. Knee flexion and extension strength test

    Measured: Baseline, 3 months, 6 months

  3. Repeated sit-to-stand test (reaction time)

    Measured: Baseline, 3 months, 6 months

  4. Systolic and diastolic blood pressure

    Measured: Baseline, 3 months, 6 months

  5. Timed up and go test (functional mobility)

    Measured: Baseline, 3 months, 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionSep 2018
  4. Study completionDec 2018

Resources

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
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
150 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02527668
Sponsor's protocol ID
2013-11-25-HyD-O
Other IDs
000000198
Status last verified
Apr 2019
First submitted
14 Aug 2015
Last updated
30 Apr 2019
Results posted
No
Data monitoring committee
No

Publications

  • Bischoff-Ferrari HA, Dawson-Hughes B, Orav JE, Ceglia L, Egli A, Kistler-Fischbacher M, Wieczorek M, de Godoi Rezende Costa Molino C. Effect of calcifediol and cholecalciferol on muscle function in postmenopausal women: a randomized controlled trial. Osteoporos Int. 2025 Jun;36(6):1007-1018. doi: 10.1007/s00198-025-07456-7. Epub 2025 Apr 9.

    PubMed 40205202

  • Ceglia L, Rivas DA, Schlogl M, Fielding GB, Egli A, Bischoff-Ferrari HA, Dawson-Hughes B. Effect of vitamin D3 vs. calcifediol on VDR concentration and fiber size in skeletal muscle. J Bone Miner Metab. 2023 Jan;41(1):41-51. doi: 10.1007/s00774-022-01374-y. Epub 2022 Nov 16.

    PubMed 36385193

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Calcifediol and Vitamin D3 in people with Osteopenia/Osteoporosis, run by dsm-firmenich Switzerland AG at 1 site in Switzerland.

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 14 inclusion and 21 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 30 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 Switzerland. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Overall assessment of the "lower extremity function" test battery (difference in proportion of those who improved or maintained function compared to those who declined in function by treatment group) (time frame: Baseline, 3 months, 6 months). 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 NCT02527668, which also lists 2 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 30 Apr 2019.

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