Health Condition 1: null- osteoporosis
Conditions
Interventions
Intervention1: Teriparatide: Daily dose of 20 mcg injection Teriparatide subcutaneously given from a multidosage Teriparatide pen for continuous 3 months
Control Intervention1: Zoledronic Acid: Single
Sponsors
IPGMER and SSKM Hospital
Eligibility
Inclusion criteria
Inclusion criteria: 1. Bone mineral density (BMD) T score reduction to -2.5SD or more at the femoral neck, total hip, or lumbar spine (L1-L4). 2. Bone mineral density (BMD) T-score of at least -1.5SD at same sites with either 1 or more atraumatic vertebral fracture(s) or an atraumatic non-vertebral fracture. Non-vertebral fracture sites allowed are wrist, humerus, clavicle, femur, tibia, hip, pelvis and ribs. 3. Ambulatory patients. 4. Free of severe systemic conditions that will impair ability to complete the trial.
Exclusion criteria
Exclusion criteria: 1. Patients without consent. 2. Patients allergic to teriparatide or zoledronic acid. 3. Received prior treatment with teriparatide, PTH, or other related medications or oral or IV bisphosphonates before entering the trial. 4. Have a moderate to severe 25(OH) vitamin D deficiency. 5. History of recent tooth extraction or recent fracture. 6. Have a family history of bone neoplasia (including Osteosarcoma, Pagetâ??s disease of bone or other bone tumor). 7. Have active liver disease or have significantly impaired kidney function. 8. Have active or recent history of significant gastrointestinal (stomach or intestinal) disorders.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Bone Mineral Density Timepoint: Before the therapy and One year after the completion of therapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Tscore and FRAX 10 years fracture risk assessmentTimepoint: Before the therapy and One year after the completion of therapy. | — |
Countries
India
Contacts
Public ContactISHITA DEY
Department of Physical Medicine and Rehabilitation, IPGMER and SSKM Hospital
Outcome results
None listed