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

April 29, 2019 updated by: DSM Nutritional Products, Inc.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • Center on Aging and Mobility, Klinik für Geriatrie, UniversitätsSpital Zürich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • 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)
  • 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

Exclusion Criteria:

  • 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
  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Calcifediol Hy.D (25-hydroxyvitamin D)
20 μg Calcifediol Hy.D (25-hydroxyvitamin D) (one capsule) per day for 6 months
Dietary supplement: Calcifediol
One capsule orally of Calcifediol (20 µg) per day with a meal for a duration of 6 months
Other Names:
  • 25-hydroxyvitamin D (Hy.D)
Active Comparator: Vitamin D3 (cholecalciferol)
3200 IU Vitamin D3 (cholecalciferol) (one capsule) per day for 6 months
Dietary supplement: Vitamin D3
One capsule orally of Cholecalciferol (3200 IU) per day with a meal for a duration of 6 months
Other Names:
  • Cholecalciferol
Placebo Comparator: Placebo
1 Placebo capsule per day for 6 months
Other: Placebo
One capsule orally of a Placebo capsule per day with a meal for a duration of 6 months

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Baseline, 3 months, 6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Gait speed measurement (8-meter walk)
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Knee flexion and extension strength test
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Repeated sit-to-stand test (reaction time)
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Systolic and diastolic blood pressure
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Timed up and go test (functional mobility)
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Bone mineral density (DXA)
Time Frame: Baseline and 6 months
spine, hip (both sides at baseline, side with lowest total femur BMD only at follow-up), radius
Baseline and 6 months
Muscle mass (DXA)
Time Frame: Baseline and 6 months
Upper and lower extremity, body composition
Baseline and 6 months
Bone quality (Xtreme CT):
Time Frame: Baseline and 6 months
Tibia (funding is pending), radius (funding is pending)
Baseline and 6 months
Cognition (MoCa test score)
Time Frame: Baseline and 6 months
MoCa: Montreal Cognitive Assessment
Baseline and 6 months
Quality of life questionnaire
Time Frame: Baseline, 3 months, 6 months
EuroQol country specific TTM Index
Baseline, 3 months, 6 months
Upper extremity test (grip strength)
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Cardiovascular fitness (6-minute walking test)
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Cardio vascular risk marker (NT-BNP)
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Bone marker: P1NP
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Bone marker: Osteocalcin
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Bone marker: Sclerostin
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Muscle marker: myostatin
Time Frame: Baseline, 3 months, 6 months
Baseline, 3 months, 6 months
Safety: Serum calcium adjusted for albumin
Time Frame: Screening, 3 months, 6 months
Screening, 3 months, 6 months
Safety: Serum creatinine
Time Frame: Screening, 3 months, 6 months
Screening, 3 months, 6 months
Safety: Urinary calcium/creatinine Ratio
Time Frame: Screening, 3 months, 6 months
Screening, 3 months, 6 months
Safety: Blood pressure
Time Frame: Screening, 3 months, 6 months
Screening, 3 months, 6 months
Safety: Pulse rate
Time Frame: Screening, 3 months, 6 months
Screening, 3 months, 6 months
Ancillary studies: Analysis of expression of the vitamin D receptor (VDR) in skeletal muscle
Time Frame: Baseline, 6 months
18 of 50 participants in active group I, active group II and control will be enrolled in the muscle biopsy ancillary study. The muscle biopsies (about 0.2 g) will be taken from mid-thigh at baseline and at 6 months follow-up. Biopsies will be taken at the Zurich site, frozen and send to the Tufts University Boston, USA for analysis. Analysis: Expression of the vitamin D receptor (VDR) in skeletal muscle
Baseline, 6 months
Ancillary studies: Analysis of total cross-sectional area (CSA) of muscle fibers
Time Frame: Baseline, 6 months
18 of 50 participants in active group I, active group II and control will be enrolled in the muscle biopsy ancillary study. The muscle biopsies (about 0.2 g) will be taken from mid-thigh at baseline and at 6 months follow-up. Biopsies will be taken at the Zurich site, frozen and send to the Tufts University Boston, USA for analysis. Analysis: Total cross-sectional area (CSA) of muscle fibers
Baseline, 6 months
Ancillary studies: Dried blood spot
Time Frame: Baseline, 3 months
Among all 150 participants, we compare 25(OH)D content in arterial finger tip blood and venous blood at baseline and at 3 months
Baseline, 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
DSM Nutritional Products, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Zurich
Tufts University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Heike Bischoff-Ferrari, Prof, Dr.PH, Center on Aging and Mobility, Klinik für Geriatrie, UniversitätsSpital Zürich

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 17, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 19, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 29, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2013-11-25-HyD-O
  • 000000198 (Other Identifier: SNCTP No.)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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