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| ID | Type | Description | Link |
|---|---|---|---|
| 2010-021009-19 | EudraCT Number |
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| Name | Class |
|---|---|
| National Institute for Health Research, United Kingdom | OTHER_GOV |
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Previously the approach to treatment of osteoporosis has been to use medications which prevent excessive resorption of bone. More recently medications that build up new bone, i.e. anabolic treatments, have been, and are being, developed. The investigators would like to develop a strategy for evaluating the effectiveness of anabolic therapies by studying a currently available therapy (teriparatide). This strategy could then be used to assess new anabolic treatments as they are developed for use in humans.
The aims of this study are 1) to fully describe the changes in bone turnover in response to teriparatide by biochemical marker type and by time; 2) to fully describe the changes in bone mineral density (BMD) in response to teriparatide by site, bone compartment and time.
If this study is able to identify an early response to treatment, then this will help speed up drug development in this area, by allowing the identification of promising new anabolic drugs and enabling us to understand their mechanism of action. This will benefit the investigators patients as the investigators will have a better understanding of how these drugs work.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | Teriparatide (Forsteo) 20 mcg subcutaneous injection once daily. Duration 104 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Volumetric bone mineral density (BMD) of the lumbar spine (mg hydroxyapatite/cm3) | Change in volumetric BMD of the lumbar spine (vertebrae L1-3) (mg hydroxyapatite/cm3) measured by quantitative computed tomography (QCT) from 0 to 104 weeks treatment. | 0 to 104 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Lumbar spine, total hip and whole body bone mineral density (g/cm2) | Changes in lumbar spine, total hip and whole body bone mineral density (g/cm2) measured by dual x-ray absorptiometry (DXA) from 0 to 104 weeks. | 0 to 104 weeks |
| Biochemical markers of bone turnover |
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Inclusion Criteria
Subjects must:
Exclusion Criteria
Patients will not be admitted to the study if they exhibit any of the following:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Eastell, MD, FRCP, FRCPath, FMedSci | University of Sheffield | Study Director |
| Jennifer Walsh, PhD MRCP | Sheffield Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Eugene McCloskey, MD, FRCPI | University of Sheffield | Principal Investigator |
| Nicola Peel, DM FRCP | Sheffield Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Angela Rogers, BSc (Hons), PhD, MCSP | University of Sheffield | Principal Investigator |
| Margaret Paggiosi, Bsc (Hons), PhD, MICR | Sheffield Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Lang Yang, PhD CSci | University of Sheffield | Principal Investigator |
| David Hughes, BMedSci MBChB PhD FRCPath | Sheffield Teaching Hospitals NHS Foundation Trust | Principal Investigator |
| Mark Wilkinson, PhD, FRCS (Tr&Orth) | University of Sheffield |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | South Yorkshire | S5 7AU | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29365099 | Derived | Gossiel F, Scott JR, Paggiosi MA, Naylor KE, McCloskey EV, Peel NFA, Walsh JS, Eastell R. Effect of Teriparatide Treatment on Circulating Periostin and Its Relationship to Regulators of Bone Formation and BMD in Postmenopausal Women With Osteoporosis. J Clin Endocrinol Metab. 2018 Apr 1;103(4):1302-1309. doi: 10.1210/jc.2017-00283. |
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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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Changes in biochemcial markers of bone turnover (OC, PINP, bone ALP, urinary NTX, serum CTX, sclerostin, DKK-1) from 0 to 104 weeks. |
| 0 to 104 weeks |
| Distal tibia and radius volumetric body bone mineral density (BMD) (mg hydroxyapatite/cm3) | Changes in distal tibia and radius volumetric bone mineral density (mg hydroxyapatite/cm3) measured by High Resolution peripheral Quantitative Computed Tomography (HR-pQCT) from 0 to 104 weeks. | 0 to 104 weeks |
| Principal Investigator |
| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |