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| Name | Class |
|---|---|
| University of Southern Denmark | OTHER |
| Copenhagen University Hospital, Denmark | OTHER |
| Esbjerg Hospital - University Hospital of Southern Denmark | OTHER |
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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.
Study Objectives
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| controlgroup | Active Comparator | Teriparatide, 20 microgram/day. 24 months of treatment |
|
| studygroup 1 | Experimental | Teriparatide, 20 microgram/day. 24 months of treatment. 12 months of Whole-body vibration on vibration platforms. |
|
| studygroup 2 | Experimental | Teriparatide, 20 microgram/day. 24 months of treatment. 24 months of Whole-body vibration on vibration platforms |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| whole-body vibration | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the BMD, Bone Mineral Density of hip and spine region (Hologic DXA machine) | DXA scan of hip and spine regions, BMD (g/cm^2) | at the time the participants start treatment and in an interval as close as possible to after 6, 12, 18, 24 months from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Bone microarchitecture at the tibia | HRpQCT assesses parameters of bone microarchitecture at the tibia. | 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 |
| Changes in the Bone microarchitecture at the radius |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Matzen, Clin.Ass.Pro | Odense University Hospital | Principal Investigator |
| Ditte Jepsen, MD, ph.d. student | University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Odense | 5000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15138664 | Background | O'Neill TW, Cockerill W, Matthis C, Raspe HH, Lunt M, Cooper C, Banzer D, Cannata JB, Naves M, Felsch B, Felsenberg D, Janott J, Johnell O, Kanis JA, Kragl G, Lopes Vaz A, Lyritis G, Masaryk P, Poor G, Reid DM, Reisinger W, Scheidt-Nave C, Stepan JJ, Todd CJ, Woolf AD, Reeve J, Silman AJ. Back pain, disability, and radiographic vertebral fracture in European women: a prospective study. Osteoporos Int. 2004 Sep;15(9):760-5. doi: 10.1007/s00198-004-1615-4. Epub 2004 May 12. | |
| 14618303 |
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| ID | Term |
|---|---|
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| Sygehus Lillebaelt |
| OTHER |
| Odense Patient Data Explorative Network | OTHER |
| Region of Southern Denmark | OTHER |
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|
| teriparatide | Drug | Teriparatide, 20 microgram/day. 24 months of treatment. |
|
|
HRpQCT assesses parameters of bone microarchitecture at the radius. |
| 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 |
| changes in muscle mass | Full body DXA | at the time the participants start treatment and in an interval as close as possible to after 12 and 24 months from baseline |
| Changes from baseline in the markers of bone resorption | CTX, sclerostin | 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 |
| Changes from baseline in the markers of bone formation | P1NP | 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 |
| Changes in Muscle strength | Measurements of muscle strength (leg extensor power) | 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 |
| Changes in handgrip strength | Measurements of muscle strength (handgrip strength) | 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 |
| Changes in Balance | Short Physical Performance Battery (SPPB) | 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 |
| Adherence to WBV | Self Reporting training log | During 2 years from the start of the treatment |
| Changes in physical activity | IPAQ short version | at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline |
| Changes in quality of life | EQ5D questionaire. | at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline |
| Changes in basic mobility | Time up and go test | 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 |
| Changes in The Falls Efficacy Scale International | FES-I | at the time the participants start treatment and in an interval as close as possible to after 12, and 24 months from baseline |
| Background |
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| 11846331 | Background | Tosteson AN, Gabriel SE, Grove MR, Moncur MM, Kneeland TS, Melton LJ 3rd. Impact of hip and vertebral fractures on quality-adjusted life years. Osteoporos Int. 2001 Dec;12(12):1042-9. doi: 10.1007/s001980170015. |
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| 32944251 | Derived | 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. |
| 31309239 | 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. |
| 29548300 | 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. |
| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |