Health Condition 1: M81- Osteoporosis without current pathological fracture
Conditions
Interventions
Intervention1: Abaloparatide Injection 3120 mcg/1.56 mL pre-filled pen: The recommended dosage of Abaloparatide Injection 3120 mcg/1.56 mL is 80 mcg administered subcutaneously once daily.
Administer
Sponsors
Precise Biopharma Pvt. Ltd.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient is a healthy ambulatory postmenopausal woman from 45 to 75 years of age (both inclusive) with the documented diagnosis of osteoporosis. 2. The patient has been postmenopausal for at least 5 years. Postmenopausal status will be established by a history of amenorrhea for at least 5 years and by an elevated serum follicle-stimulating hormone (FSH) value of greater than or equal to 30 IU/L. 3. The patient has a bone mineral density T-score less than or equal to -2.5 and greater than -5.0 at the lumbar spine (L1-L4) or hip (femoral neck) by dual energy x-ray absorptiometry (DXA) and radiological evidence of 2 or more mild or one or more moderate lumbar or thoracic vertebral fractures, or history of low trauma forearm, humerus, sacral, pelvic, hip, femoral, or tibial fracture within the past 5 years. Postmenopausal women older than 65 who meet the above fracture criteria but have a T-score less than or equal to -2.0 and greater than -5.0 may be enrolled. Women older than 65 who do not meet the fracture criteria may be enrolled if their T-score is less than or equal to -3.0 and greater than -5.0. 4. The patient is in good general health as determined by medical history and physical examination (including vital signs), has a body mass index (BMI) of 18.5 to 33 kg/m2 (both inclusive), and is without evidence of clinically significant abnormality in the opinion of the Investigator. 5. Any required concomitant medications which are not excluded (e.g., statins or antihypertensives) may be continued through the study. Every effort should be made to maintain the medication at a stable dose throughout the study, patient to the Investigator s medical judgment. 6. The patient has serum calcium (albumin-corrected), PTH (1-84), serum phosphorus and alkaline phosphatase values all within the normal range during the screening period. Patients with minor elevations or reductions in serum calcium may be enrolled if serum ionized calcium is normal. Any patient with an elevated alkaline phosphatase value, and who meets all other entry criteria, would be required to have a normal bone-specific alkaline phosphatase result to be enrolled. 7. The patient has serum 25-hydroxy Vitamin D values above 15 ng/mL and within 3 times the upper normal range. 8. The patient s resting 12-lead electrocardiogram obtained during screening shows no clinically significant abnormality and QTc less than or equal to 470 msec (Bazett s correction). 9. The patient s systolic blood pressure is greater than or equal to 100 and less than or equal to 155 mmHg, diastolic blood pressure is greater than or equal to 40 and less than or equal to 95 mmHg, and heart rate is greater than or equal to 45 and less than or equal to 100 bpm (sitting or supine). 10. The patient has no clinically significant abnormality of serum hemoglobin, hematocrit, WBC and platelets, or usual serum biochemistry: electrolytes, renal function, liver function and serum proteins. 11. The patient has read, understood, and signed the written informed consent form, which must have been obtained prior to screening. 12. Patients willing to comply with the protocol requirements.
Exclusion criteria
Exclusion criteria: General exclusion criteria: 1. Patients with a history of more than four spine fractures, mild or moderate, or any severe fractures. 2. Patients with presence of abnormalities of the lumbar spine that would prohibit assessment of spinal bone mineral density, defined as having at least two radiologically evaluable vertebrae within L1-L4. 3. Patients with unevaluable hip bone mineral density or patients who have undergone bilateral hip replacement (unilateral hip replacement is acceptable). 4. Patients with a history of bone disorders (e.g., Paget s disease) other than postmenopausal osteoporosis. 5. Patients with unexplained elevation of serum alkaline phosphatase. 6. Patients with a history of radiotherapy (radiation therapy), other than radioiodine. 7. Patients with a history of chronic or recurrent renal, hepatic, pulmonary, allergic, cardiovascular, gastrointestinal, endocrine, central nervous system, hematologic, or metabolic diseases or immunologic, emotional, and/or psychiatric disturbances to a degree that would interfere with the interpretation of study data or compromise the safety of the patient. 8. Patients with a history of Cushing s disease, hyperthyroidism, hypo- or hyperparathyroidism, or malabsorptive syndromes within the past year. 9. Patients with a history of significantly impaired renal function (serum creatinine greater than 2.0 mg/dL). 10. Patients with a history of any cancer within the past 5 years. 11. Patients with a history of osteosarcoma at any time. 12. Patients with a history of nephrolithiasis or urolithiasis within the past 5 years. 13. Patients with decrease of 20 mmHg or more in systolic blood pressure or 10 mmHg or more in diastolic blood pressure from supine to standing (5 minutes lying and 3 minutes standing) and/or any symptomatic hypotension at screening. 14. Patients known to be positive for Hepatitis B, Hepatitis C, HIV-1, or HIV-2. Medication-related exclusion criteria: 15. Patients with a known history of hypersensitivity to any of the test materials or related compounds. 16. Patients with prior treatment with PTH or PTHrP drugs. 17. Patients with prior treatment with bisphosphonates [patients who had a short course of bisphosphonate treatment (3 months or less) and were intolerant of the treatment are not excluded from study participation], fluoride or strontium in the past 5 years, prior treatment with gallium nitrate, or with as yet unapproved bone-acting investigational agents at any time. 18. Patients with prior treatment with Denosumab, Calcitonin, selective estrogen receptor modulators (such as Raloxifene or Tamoxifen), Tibolone, or anabolic steroids in the past 12 months. Estrogens administered as hormone replacement therapy, with or without progestins, are not exclusionary. 19. Patients treatment with anticonvulsants that affect Vitamin D metabolism (Phenobarbital, Phenytoin, Carbamazepine, or Primidone) or with chronic heparin within the 6 months prior to the screening period. 20. Patients daily treatment with oral, intranasal, or inhaled corticosteroids within the 12 months prior to the screening period. Occasional use of corticosteroids (for seasonal allergies or asthma) is not exclusionary. 21. Patients with exposure to general anesthesia within the 12 weeks prior to the screening period. 22. Patients with exposure to an
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in Bone Mineral Density (BMD) at 24 weeks Lumbar spine (L1-L4) BMD Total hip BMD Femoral neck BMD Timepoint: Visit 1 - Screening visit (Up to 2 weeks) Visit 5 - Follow up visit / Week 12 (Day 85 4) Visit 7 - End of treatment (EOT) visit / Week 24 (Day 169 4) | — |
Secondary
| Measure | Time frame |
|---|---|
| Percent change in Bone Turnover Markers (BTMs) at 24 weeks P1NP (Procollagen Type 1 N-terminal Propeptide) Bone formation marker CTX (C-terminal Telopeptide of Type 1 Collagen) Bone resorption marker Timepoint: Visit 1 - Screening visit (Up to 2 weeks) Visit 5 - Follow up visit / Week 12 (Day 85 4) Visit 7 - End of treatment (EOT) visit / Week 24 (Day 169 4) ;Time to maximum suppression of CTX (bone resorption marker)Timepoint: Visit 1 - Screening visit (Up to 2 weeks) Visit 5 - Follow up visit / Week 12 (Day 85 4) Visit 7 - End of treatment (EOT) visit / Week 24 (Day 169 4);Correlation between BTM changes and BMD improvementTimepoint: Visit 1 - Screening visit (Up to 2 weeks) Visit 5 - Follow up visit / Week 12 (Day 85 4) Visit 7 - End of treatment (EOT) visit / Week 24 (Day 169 4);Proportion of patients achieving greater than or equal to 3 percent increase in Lumbar Spine BMD at 24 weeksTimepoint: Visit 1 - Screening visit (Up to 2 weeks) Visit 5 - Follow up visit / Week 12 (Day 85 4) Visit 7 - End of treatment (EOT) visit / Week 24 (Day 169 4);Treatment emergent adverse events reported during the study.Timepoint: Throughout the Study.;Serious adverse events (SAE) reported during the study.Timepoint: Throughout the Study.;Changes in serum calcium levels (risk of hypercalcemia/hypocalcemia)Timepoint: Visit 3 - Randomization visit (Day 1) Visit 4 - Follow up visit / Week 4 (Day 29 4) Visit 5 - Follow up visit / Week 12 (Day 85 4) Visit 6 - Follow up visit / Week 18 (Day 127 4);Orthostatic hypotension eventsTimepoint: Visit 3 - Randomization visit (Day 1) Visit 4 - Follow up visit / Week 4 (Day 29 4) Visit 5 - Follow up visit / Week 12 (Day 85 4) Visit 6 - Follow up visit / Week 18 (Day 127 4) Visit 7 - End of treatment (EOT) visit / Week 24 (Day 169 4) | — |
Countries
India
Contacts
Public ContactMr Vipen Seth
Clinwave Research Pvt. Ltd.
Outcome results
None listed