Clinical trial NCT02563353: PTH and Vibration in OSteoporosis Study
Official title: PTH and Vibration in OSteoporosis (PaVOS) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Osteoporosis
Keywords: whole body vibration
PTH
Lead sponsor: Odense University Hospital
Sponsor class: OTHER
Collaborators: name: University of Southern Denmark
name: Copenhagen University Hospital, Denmark
name: Esbjerg Hospital - University Hospital of Southern Denmark
name: Sygehus Lillebaelt
name: Odense Patient Data Explorative Network
name: Region of Southern Denmark
First posted: 2015-09-30
Enrollment: 35
Sex: FEMALE
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective:

This is a randomized controlled trial (RCT) in osteoporosis patients randomized to standard parathyroid hormone (PTH) treatment alone or to standard PTH treatment and Whole-body vibration (WBV). PTH is an effective but expensive anabolic treatment for osteoporosis. WBV stimulates muscles and bones. A combined treatment might have synergistic or additive beneficial effects on bone, reducing fracture risk making treatment more effective and cost-effective. A beneficial effect on muscles and thereby falls risk of WBV may improve fracture risk even further.

If the results of this pilot study are promising then a strong case can be made for a large multi-centre RCT using strong endpoints including fractures and falls.

Detailed description: Study Objectives

1. To determine if WBV in addition to standard PTH treatment has a greater effect on bone mass in osteoporosis patients compared to standard PTH treatment alone.
2. To determine if WBV in addition to standard PTH treatment has a greater effect on bone microarchitecture in osteoporosis patients compared to standard PTH treatment alone, as assessed by high resolution peripheral quantitative computed tomography (HR-pQCT).
3. To determine if WBV in addition to standard PTH treatment has a greater effect on markers of bone formation and resorption in osteoporosis patients compared to standard PTH treatment alone.
4. To study the effects of WBV on muscle function and balance in osteoporosis
5. To assess the safety and adherence to WBV in osteoporotic patients

Study Design:

General Design This will be a multi-center randomized controlled trial (RCT) in osteoporosis patients being started on standard PTH treatment according to Danish Osteoporosis guidelines. Participants will be randomized to standard PTH treatment alone or to standard PTH treatment and WBV.

Statistical Plan:

Sample Size Determination The inclusion of 32 participants (16 in both groups) would give the study 80% power to detect a clinically significant additional increase of 22% with WBV (assuming a 9% increase of BMD in the PTH alone group and 11% increase in the combined PTH+WBV group, and assuming a SD of the BMD increase of 2%. Allowing for a 20% dropout rate, the plan is to include 40 participants (20 in each group). From previous research on WBV by one of the investigators (TM), statistically significant differences were found in bone formation markers and in muscle strength at 3 months between the WBV and control groups with a sample size of 35. The number of participants in the latter pilot work is reassuringly consistent with the sample size calculations. The number needed to be included is far less (34%) than the actual number of patients treated with PTH in the recruiting departments in a similar time period last year.

Statistical Methods:

STATA/SPSS will be used for data analysis. For the primary endpoint (BMD at 12 months) the mean percentage changes in BMD between the two groups will be compared using Analysis of Variance (ANOVA) provided the distribution is normal. For the other endpoints parametric tests will be used to assess differences in the two groups for normally distributed data and non-parametric tests for data not normally distributed.

The randomization will be done online in the data capture program Red Cap. There will be created a Data dictionary that contains detailed descriptions of each variable used by the registry, including the source of the variable, and normal ranges if relevant.

Information:

Participants will be recruited during their attendance at the outpatient clinics. At that time the subjects will be given a full explanation of the study as well as the patient information sheet and invited to participate in the study. At an interval of not less than 24 hours, patients will be invited to consent prior to starting their PTH treatment.

The information will be sufficient for subjects to make an informed decision about their participation in this study. The subject will complete and sign a consent form to indicate they are giving valid consent to participate in the trial.

Withdrawal of Subjects:

Patients who withdraw consent from participation in the trial will be withdrawn from the trial. This will not affect their standard medical management and not cause any adverse effect on the subject.

Eligibility criteria: Inclusion Criteria:

* Women starting PTH treatment for osteoporosis according to Danish Osteoporosis guidelines

Exclusion Criteria:

* Women currently taking oral glucocorticoids
* Women unable to give informed consent
* Women unable to stand for 2 minutes at a time on the vibration platform
* Women who have contraindications to WBV (e.g. joint prosthesis, pacemakers)

Primary outcomes:
measure: Changes in the BMD, Bone Mineral Density of hip and spine region (Hologic DXA machine)
timeFrame: at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18, 24 months from baseline
Secondary outcomes:
measure: Changes in the Bone microarchitecture at the tibia
timeFrame: at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18 and 24 months from baseline
measure: Changes in the Bone microarchitecture at the radius
timeFrame: at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18 and 24 months from baseline
measure: changes in muscle mass
timeFrame: at the time the participants start treatment and in an interval as close as possible to after 12 and 24 months from baseline
measure: Changes from baseline in the markers of bone resorption
timeFrame: at the time the participants start treatment and in an interval as close as possible to after 3, 6, 12, 18, 24 months from baseline
measure: Changes from baseline in the markers of bone formation
timeFrame: at the time the participants start treatment and in an interval as close as possible to after 3, 6, 12, 18, 24 months from baseline
measure: Changes in Muscle strength
timeFrame: at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline
measure: Changes in handgrip strength
timeFrame: at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline
measure: Changes in Balance
timeFrame: at the time the participants start treatment and in an interval as close as possible to after 3, 6 ,12, 18 and 24 months from baseline
measure: Adherence to WBV
timeFrame: During 2 years from the start of the treatment
measure: Changes in physical activity
timeFrame: at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
measure: Changes in quality of life
timeFrame: at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
measure: Changes in basic mobility
timeFrame: at the time the participants start treatment and in an interval as close as possible to after 3,6,12,18 and 24 months from baseline
measure: Changes in The Falls Efficacy Scale International
timeFrame: at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline
Other outcomes:
Locations:
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Odense University Hospital
name: Lars Matzen, Clin.Ass.Pro
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southern Denmark
name: Ditte Jepsen, MD, ph.d. student
role: PRINCIPAL_INVESTIGATOR
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