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Increased bone formation in the absence of accelerated resorption is resulting in a marked anabolic response to teriparatide (TPTD) during the early phase after treatment initiation. Months later, due to coupling mechanism, the sustained increase of bone formation and ongoing anabolic effects are accompanied by significantly increased bone resorption as well. Antiresorptives influence the balance of bone formation and resorption. Therefore the investigators aim is to investigate the effects of the addition of antiresorptives to the second half of TPTD cycle when resorption is already also markedly elevated.
We prospectively randomize 125 postmenopausal women after 9 months of TPTD treatment into three different open-label groups for another 9 months: either alendronate (ALN, 70 mg/week), raloxifene (RAL, 60 mg/day) or no medication (TPTD mono) on top of ongoing TPTD treatment.
All subjects receive daily supplementation of 1000mg calcium and 800 IU vitamin D.
Serum level of intact amino terminal propeptide of type I procollagen (PINP) and type 1 collagen cross-linked C-telopeptide (CTX) as well as DXA measurement at the spine, total hip and femoral neck BMD are evaluated at TPTD treatment initiation, at baseline of randomization to antiresorptive therapy as well as at 3 and 9 months during the combination treatment.Volumetric BMD values will be also determined.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide | Active Comparator | 18 months of daily 20 ug sc. teriparatide monotherapy (TPTD) |
|
| Teriparatide and Raloxifene | Active Comparator | 9 months teriparatide 20 ug/day sc. monotherapy (TPTD) continued by combination therapy of raloxifene 60 mg/day orally(RAL)and TPTD for another 9 months |
|
| Teriparatide and Alendronate | Active Comparator | 9 months teriparatide monotherapy 20 ug/day sc.(TPTD) continued by combination therapy of alendronate 70 mg/week orally(ALN)and TPTD for another 9 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| teriparatide | Drug | teriparatide 20 ug/day, sc. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Differences in changes of areal lumbar spine BMD between the three treatment groups | Primary objective To investigate the changes in lumbar spine BMD of patients among the three treatment groups | Evaluation after 9, 12 and 18 months of TPTD |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in changes of BMDs and markers of bone turnover among the three treatment groups after 18 months TPTD treatment | Secondary objectives
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christian Muschitz, M.D. | Medical University of Vienna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical University of Vienna | Vienna | State of Vienna | 1060 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24619763 | Derived | Muschitz C, Kocijan R, Fahrleitner-Pammer A, Pavo I, Haschka J, Schima W, Kapiotis S, Resch H. Overlapping and continued alendronate or raloxifene administration in patients on teriparatide: effects on areal and volumetric bone mineral density--the CONFORS Study. J Bone Miner Res. 2014 Aug;29(8):1777-85. doi: 10.1002/jbmr.2216. |
| Label | URL |
|---|---|
| Homepage of Medical Department II, Vienna (German) | View source |
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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 |
| D020849 | Raloxifene Hydrochloride |
| D019386 | Alendronate |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
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| teriparatide and raloxifene | Drug | teriparatide 20 ug/day sc. raloxifene 60mg oral daily |
|
|
| teriparatide and alendronate | Drug | teriparatide 20 ug/day sc. alendronate 70mg oral weekly |
|
|
| Evaluation after 9, 12 and 18 months of TPTD treatment |
| D009750 |
| Nutritional and Metabolic Diseases |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D013629 | Tamoxifen |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004164 | Diphosphonates |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |