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Phase III, prospective, randomized, parallel, double blind, placebo-controlled study to determine whether Teriparatide can accelerate bone healing in unstable intertrochanteric fracture patients treated with Proximal Femoral Nail Antirotation (PFNA) assessed by radiographic and clinical outcomes.
Patients will undergo screening assessment to determine the eligibility for study participation and will be randomized in 1:1 ratio to receive Teriparatide 20 μg or placebo subcutaneous once daily for 12 weeks.
All patients will receive supplements of 1000 mg/day of elemental calcium and 20,000 IU/week of vitamin D2.
Patients will be scheduled to clinic visit for radiographic and clinical assessment at 2, 6,12 and 24 weeks postoperatively. Each participant will be in the study for 6 months in total.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Teriparatide | Experimental | Teriparatide 20 μg subcutaneous once daily for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo subcutaneous once daily for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | Teriparatide 20 μg subcutaneous once daily for 12 weeks (Patient self administration at home by pen injector) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to healing assessed by radiographic evidence | Fracture is judged to be healed radiographically if bridging callus was evident on 3 of 4 cortices as seen on two views (cortical bridging of three cortices) | from randomization, assessed up to 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evidence of healing assessed by Harris Hip Score as one of functional outcomes | Harris Hip Score (90-100: Excellent, 80-89: Good, 70-79: Fair, <70 poor) | from randomization, assessed up to 24 months |
| Clinical evidence of healing assessed by weight bearing ability as one of functional outcomes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Prof.Dr.Aree Tanavalee, M.D. | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Chulalongkorn University | Bangkok | 10330 | Thailand |
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The patients will be randomized in 1:1 ratio to receive Teriparatide or placebo
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double blind, placebo-controlled
| Placebo | Drug | Placebo subcutaneous once daily for 12 weeks. (Patient self administration at home by pen injector) |
|
| Calcium supplement | Dietary Supplement | 1000 mg/day of elemental calcium |
|
| Vitamin D | Dietary Supplement | 20,000 IU/week of vitamin D2 |
|
Weight bearing ability (Non weight bearing, Partial weight bearing, Full weight bearing) |
| from randomization, assessed up to 24 months |
| Clinical evidence of healing assessed by walking ability as one of functional outcomes | Walking ability (Independent walking, Assisted walking, Bedridden) | from randomization, assessed up to 24 months |
| ID | Term |
|---|---|
| D019379 | Teriparatide |
| D014807 | Vitamin D |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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