Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
40 postmenopausal women, with a non-operated proximal humeral fracture, will be randomized to standard treatment (physiotherapy) or standard treatment + Forsteo (rhPTH 1-34) during 4 weeks. Follow-up will be at 7 weeks and 3 months including x-ray and DASH score (The Disabilities of the Arm, Shoulder and Hand) measuring physical function, and pain on a visual analoge scale (VAS).
Two doctors, blinded to the treatment, will judge the callus formation and healing on the x-rays and guess the treatment. The DASH score and the pain score will be compared between the treatment groups.
The investigators hypotheses are that callus formation and healing will be more pronounced and that patients have less pain and better function in the rhPTH 1-34 group.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Proximal humeral fracture - intervention | Experimental | 20 patients will be randomized to 20 micrograms daily of Teriparatide (Forsteo) |
|
| Proximal humeral fracture | No Intervention | 20 patients will receive standard treatment (physiotherapy) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Teriparatide | Drug | Teriparatide (Forsteo) 20 micrograms daily during four weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Callus formation and fracture healing at 7 weeks judged by a blinded assessor who will guess the treatment | 7 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Function | The function in the upper extremity will be measured using DASH. The experimental group will be compared with the control group | 7 weeks and 3 months |
| Pain | Pain at rest and during activity will be measured using a visual analogue scale (VAS). The experimental group will be compared with the control group |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lasarettet i Motala | Motala | Sweden | ||||
| Department of Orthopaedics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19594305 | Result | Aspenberg P, Genant HK, Johansson T, Nino AJ, See K, Krohn K, Garcia-Hernandez PA, Recknor CP, Einhorn TA, Dalsky GP, Mitlak BH, Fierlinger A, Lakshmanan MC. Teriparatide for acceleration of fracture repair in humans: a prospective, randomized, double-blind study of 102 postmenopausal women with distal radial fractures. J Bone Miner Res. 2010 Feb;25(2):404-14. doi: 10.1359/jbmr.090731. | |
| 20367417 |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Oct 22, 2015 | |
| Reset | Nov 24, 2015 | |
| Release | Jan 20, 2016 | |
| Reset | Feb 16, 2016 | |
| Release | Feb 17, 2016 | |
| Reset | Mar 11, 2016 | |
| Release | May 16, 2016 | |
| Reset | Jun 23, 2016 | |
| Release | Sep 19, 2017 | |
| Reset | Jul 12, 2018 | |
| Release | Apr 28, 2021 | |
| Reset | May 18, 2021 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Oct 22, 2015 | Nov 24, 2015 | |||
| Jan 20, 2016 |
| ID | Term |
|---|---|
| D006810 | Humeral Fractures |
| D012784 | Shoulder Fractures |
| ID | Term |
|---|---|
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
| D000070599 | Shoulder Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D019379 | Teriparatide |
| ID | Term |
|---|---|
| D010281 | Parathyroid Hormone |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 7 weeks and 3 months |
| Norrköping |
| Sweden |
| Result |
| Aspenberg P, Johansson T. Teriparatide improves early callus formation in distal radial fractures. Acta Orthop. 2010 Apr;81(2):234-6. doi: 10.3109/17453671003761946. |
| 26179771 | Derived | Johansson T. PTH 1-34 (teriparatide) may not improve healing in proximal humerus fractures. A randomized, controlled study of 40 patients. Acta Orthop. 2016 Feb;87(1):79-82. doi: 10.3109/17453674.2015.1073050. Epub 2015 Jul 15. |
| Feb 16, 2016 |
| Feb 17, 2016 | Mar 11, 2016 |
| May 16, 2016 | Jun 23, 2016 |
| Sep 19, 2017 | Jul 12, 2018 |
| Apr 28, 2021 | May 18, 2021 |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |