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| Name | Class |
|---|---|
| AO Trauma Middle East and North Africa | UNKNOWN |
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This study is being conducted with the aim of comparing the time to bone healing after surgery for fragility fractures of proximal femur between patients receiving strontium ranelate and placebo. Patients recruited are of 60 years of age and above. Bone healing will be assessed on clinical parameters when patient is able to ambulate full weight bearing without pain and on Xray images using RUSH score. Moreover Dexa scan will be performed pre-operatively and at 3 months postoperatively. The findings of this study will help in setting up guidelines for treatment of fragility proximal femur fractures in our population as there is still paucity of literature on effectiveness of strontium ranelate from our part of the world.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Strontium group | Active Comparator | Trial drug given in the form of sachet 2gm/sachet once every day |
|
| Placebo (Lactose) | Placebo Comparator | Look, smell, taste alike lactose 2gm/sachet in form of sachet |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Strontium Ranelate | Drug | Dual mode of action, anabolic and anti-resorptive |
|
| Measure | Description | Time Frame |
|---|---|---|
| change in Radiological healing on radiographs | Difference in RUSH (Radiological Healing score for hip) score measured at 12 weeks and 24 weeks | 12 weeks and 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| change Bone mineral density through DEXA scan | Difference in bone density T scores between pre-op and 3 months studies | pre-operatively or peri-admission and at 3 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marij Zahid, MSc. MBBS | Contact | +92-302-2302165 | marijzh@gmail.com | |
| Dr. Rizwan H Rashid, FCPS | Contact | +92-2134864350 | rizwan.haroonrashid@aku.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University Hospital | Recruiting | Karachi | Sindh | 74800 | Pakistan |
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| ID | Term |
|---|---|
| D050723 | Fractures, Bone |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| C081587 | strontium ranelate |
| C046434 | lacto-N-hexaose |
| D007785 | Lactose |
| ID | Term |
|---|---|
| D004187 | Disaccharides |
| D009844 | Oligosaccharides |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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| Lacto-N-Hexaose | Drug | Placebo look alike drug |
|
|
| D000073893 |
| Sugars |