Fragility fractures due to osteoporosis
Conditions
Interventions
Alfarol 0.5 microgram+ calcium lactate 2 x 2 g (or calcium aspartate 2 x 800 mg)/day
Teriparatide 56.5 microgram /week Alfarol 0.5microgram + calcium lactate 2 x 2 g (or calcium aspartate 2 x 800 mg)
Sponsors
Osaka University
Minoh City Hospital, Kita-Osaka Police Hospital, Osaka Koseinenkin Hospital, Hoshigaoka Koseinenkin Hospital, Kyoritsu Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Patients with osteoporosis who have incurred a new bone fracture [bone density (YAM value) of less than 70% for either the lumbar spine, healthy femur or healthy forearm, or previous fragility fracture (fracture due to a mild external force)] and those with radial fracture or proximal femoral fracture subject to open reduction and internal fixation (for the vertebral body, patients subject to conservative treatment). 2) Patients 20 years of age or over at the time of providing consent. 3) Patients who could provide written consent for participation.
Exclusion criteria
Exclusion criteria: 1)Patients believed to be at high risk of developing the following osteosarcomas: (1) Paget's disease of bone (2) Patients exhibiting elevated alkaline phosphatase levels of unknown origin (3) Infant and young patients in which the epiphysesal line is not closed (4) Patients who have received radiation therapy believed to have affected the bones 2) Hypercalcemic patients 3) Patients with a primary malignant osteosarcoma or metastatic osteosarcoma 4) Patients with metabolic bone disease other than osteoporosis (hyperparathyroidism), Administration was possible if, in patients with a history of secondary hyperparathyroidism, the PTH could be normalized by administration of vitamin D and calcium preparations 5) Pregnant or lactating women, or women who may be pregnant 6) Patients with a history of hypersensitivity to the agents used in this study or to similar compounds 7) Patients with kidney stones 8) Patients with severe renal failure (except when eGFR <30 mL /min/1.73 m2) 9) Patients in a comatose state or those in a state of circulatory collapse 10) Patients strongly under the effect of central nervous system depressants such as barbiturates or narcotics 11) Patients receiving administration of adrenalin 12) Patients who cannot give consent themselves (dementia, etc.) 13) Patients with a history of receiving preparations for PTH 14) Patients who are deemed unsuitable by the attending physician
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Radius: Bone union following surgery in patients with distal radius fragility fractures Femur: Bone union following surgery in patients with proximal femoral fragility fractures Vertebral body: Bone union in conservative treatment of the vertebral body in patients with fragility fractures The two treatment groups were compared by assessing the presence or absence of porosis in the fracture area by X-ray and CT at 8 weeks and 12 weeks following surgery to determine bone union and assessing instability in the vertebral body by X-ray. | — |
Secondary
| Measure | Time frame |
|---|---|
| QOL, bone mass measurement by DXA (lumbar spine, radius (contralateral), proximal femur), bone formation marker (serum P1NP), one resorption marker (TRACP-5b), ucOC, Ca, P, DASH, PRWE-J, grasping power, and periodic change in SF36 were compared between the two treatment groups. | — |
Countries
Japan
Contacts
Public ContactKosuke Ebina
Osaka University Graduate School of Medicine Orthopaedic Surgery
Outcome results
None listed