Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
NA
Total Enrollment
35 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-11-30
Study Completion Date
2019-11-30
Brief Summary
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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.
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.
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Detailed Description
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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.
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.
Conditions
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Osteoporosis
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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controlgroup
Teriparatide, 20 microgram/day. 24 months of treatment
Group Type
ACTIVE_COMPARATOR
teriparatide
Intervention Type
DRUG
Teriparatide, 20 microgram/day. 24 months of treatment.
studygroup 1
Teriparatide, 20 microgram/day. 24 months of treatment.
12 months of Whole-body vibration on vibration platforms.
Group Type
EXPERIMENTAL
whole-body vibration
Intervention Type
OTHER
Whole-body vibration on vibration platforms. 30-40 Hertz, from 2 mm (low) to 4 mm (high) amplitude,
1 minutes x 6 with 1 minute break between. 3 times a week.
teriparatide
Intervention Type
DRUG
Teriparatide, 20 microgram/day. 24 months of treatment.
studygroup 2
Teriparatide, 20 microgram/day. 24 months of treatment.
24 months of Whole-body vibration on vibration platforms
Group Type
EXPERIMENTAL
whole-body vibration
Intervention Type
OTHER
Whole-body vibration on vibration platforms. 30-40 Hertz, from 2 mm (low) to 4 mm (high) amplitude,
1 minutes x 6 with 1 minute break between. 3 times a week.
teriparatide
Intervention Type
DRUG
Teriparatide, 20 microgram/day. 24 months of treatment.
Interventions
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whole-body vibration
Whole-body vibration on vibration platforms. 30-40 Hertz, from 2 mm (low) to 4 mm (high) amplitude,
1 minutes x 6 with 1 minute break between. 3 times a week.
Intervention Type
OTHER
teriparatide
Teriparatide, 20 microgram/day. 24 months of treatment.
Intervention Type
DRUG
Other Intervention Names
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vibration therapy
PTH
Eligibility Criteria
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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)
* 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)
Minimum Eligible Age
50 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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University of Southern Denmark
OTHER
Sponsor Role
collaborator
Copenhagen University Hospital, Denmark
OTHER
Sponsor Role
collaborator
Esbjerg Hospital - University Hospital of Southern Denmark
OTHER
Sponsor Role
collaborator
Sygehus Lillebaelt
OTHER
Sponsor Role
collaborator
Odense Patient Data Explorative Network
OTHER
Sponsor Role
collaborator
Region of Southern Denmark
OTHER
Sponsor Role
collaborator
Odense University Hospital
OTHER
Sponsor Role
lead
Responsible Party
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Lars Matzen
MD, Clin. Ass. Professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Lars Matzen, Clin.Ass.Pro
Role: PRINCIPAL_INVESTIGATOR
Odense University Hospital
Ditte Jepsen, MD, ph.d. student
Role: PRINCIPAL_INVESTIGATOR
University of Southern Denmark
Locations
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Odense University Hospital
Odense, , Denmark
Site Status
Countries
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Denmark
References
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Sitja Rabert M, Rigau Comas D, Fort Vanmeerhaeghe A, Santoyo Medina C, Roque i Figuls M, Romero-Rodriguez D, Bonfill Cosp X. Whole-body vibration training for patients with neurodegenerative disease. Cochrane Database Syst Rev. 2012 Feb 15;(2):CD009097. doi: 10.1002/14651858.CD009097.pub2.
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Jepsen DB, Masud T, Holsgaard-Larsen A, Hansen S, Jorgensen NR, Ryg J. The combined effect of parathyroid hormone (1-34) and whole-body vibration exercise on physical performance in OSteoporotic women (PaVOS study): a secondary analysis from a randomised controlled trial. BMC Sports Sci Med Rehabil. 2020 Sep 5;12:54. doi: 10.1186/s13102-020-00204-w. eCollection 2020.
Reference Type
DERIVED
Jepsen DB, Ryg J, Hansen S, Jorgensen NR, Gram J, Masud T. The combined effect of Parathyroid hormone (1-34) and whole-body Vibration exercise in the treatment of postmenopausal OSteoporosis (PaVOS study): a randomized controlled trial. Osteoporos Int. 2019 Sep;30(9):1827-1836. doi: 10.1007/s00198-019-05029-z. Epub 2019 Jul 15.
Reference Type
DERIVED
Jepsen DB, Ryg J, Jorgensen NR, Hansen S, Masud T. The combined effect of Parathyroid hormone (1-34) and whole-body Vibration exercise in the treatment of OSteoporosis (PaVOS)- study protocol for a randomized controlled trial. Trials. 2018 Mar 16;19(1):186. doi: 10.1186/s13063-018-2551-5.
Reference Type
DERIVED
Other Identifiers
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S-20150121
Identifier Type: -
Identifier Source: org_study_id
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