CTRI/2025/09/095133 [Registered on: 19/09/2025] Trial Registered Prospectively
Last Modified On:
09/10/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to study effects of Abaloparatide Injection in the Treatment of Postmenopausal Women with Osteoporosis.
Scientific Title of Study
A Phase III, Randomized, Open Label, Active Controlled, Prospective, Parallel Group, Comparative, Multicentric Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Abaloparatide Injection in Comparison with Teriparatide Injection for the Treatment of Postmenopausal Women with Osteoporosis at High Risk for Fracture.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT/2024/41, version No. 00, dated 22-JUL-2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.), Hyderabad.
Medchal TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Scientific Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.), Hyderabad.
TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Public Query
Name
Mr Vipen Seth
Designation
President – Drug Regulatory Affairs
Affiliation
Precise Biopharma Pvt. Ltd.
Address
E-311, E-312, Eastern Business District, LBS Road, Bhandup (W), Mumbai.
Mumbai (Suburban) MAHARASHTRA 400078 India
Phone
8860833301
Fax
Email
vipen@precisegroup.co.in
Source of Monetary or Material Support
Precise Biopharma Pvt. Ltd., E-311, E-312, Eastern Business District, LBS Road, Bhandup (W), Mumbai-400078, Maharashtra, India.
Primary Sponsor
Name
Precise Biopharma Pvt. Ltd.,
Address
E-311, E-312, Eastern Business District, LBS Road, Bhandup (W), Mumbai-400078, Maharashtra, India.
Research Room, 5, Anveshan Row House, Opp. Umiya Mata Mandir, Bopal-Ghuma Main Road, Bopal Ghuma, Ahmedabad-380058. Ahmadabad GUJARAT
7574814462
drprateek239@gmail.com
Dr Nakul H Shivaramaiah
Abhayahasta Multispeciality Hospital
Research Room, 347/247, 2nd Cross, Kaggadasapura Main Road, CV Raman Nagar, Bengaluru (Bangalore)-560093.
Bangalore KARNATAKA
9611101801
cr@abhayahastahospital.com
Dr Patro Bishnu Prasad
All India Institute of Medical Sciences
Department of Orthopaedics, Room No. 14, Ground Floor, OPD Building, Sijua, Patrapada, Bhubaneswar-751019. Khordha ORISSA
9437182313
bisbnucolours@gmail.com
Dr Shah Keyur Rajendrakumar
Ananta Multispeciality Hospital
Research Room, 4th Floor (416-418), Centre Point, Opp. Vrundavan Heights, Vandemataram City to Savvy Swaraj Road, Chenpur, Gota, Ahmedabad-382470. Ahmadabad GUJARAT
9909032566
keyur.dct@gmail.com
Dr Bhanoth Valya
Gandhi Hospital
In Patient Block, Ground Floor, Department of Orthopaedics, Musheerabad, Secunderabad-500003. Hyderabad TELANGANA
9000537799
drvalyaortho@gmail.com
Dr Neerav Anand Singh
Gangasheel Advanced Medical Research Institute
Research Room, C17, Deen Dayal Puram, Rajendra Nagar, Bareilly-243122. Bareilly UTTAR PRADESH
6394503371
gangasheel.cr@gmail.com
Dr B Gowtham
Great Eastern Medical School and Hospital
Research Room, Ragolu, Srikakulam-532484. Srikakulam ANDHRA PRADESH
9441378620
drbgowthamresearch@gmail.com
Dr Rohit Nath
GSVM Medical College
Department of Orthopaedics, LLR Hospital, Swaroop Nagar, Kanpur-208002.
Kanpur Nagar UTTAR PRADESH
8009984893
nath.ortho@gmail.com
Dr Rakesh Verma
Jawahar Lal Nehru (J.L.N) Medical College
Research Room, Kala Bagh, Ajmer-305001.
Ajmer RAJASTHAN
9460077585
rakeshverma.jln@outlook.com
Dr Rajani Kumar Giddi
King George Hospital
Department of Orthopaedics, Andhra Medical College, Maharanipeta, Visakhapatnam-530002. Visakhapatnam ANDHRA PRADESH
9440560642
drgrajanikumarresearch@gmail.com
Dr Ravi Pavan Kumar
Latha Super Specialities Hospital
Research Room, D. No.: 29-14-58, Prakasam Road, Suryaraopet, Vijayawada-520002. Guntur ANDHRA PRADESH
9949584335
ravi.pavankumar@gmail.com
Dr Vikalp Vashishitha
Maharaja Agrasen Superspeciality Hospital
Research Room, Central Spine, Agrasen Aspatal Marg, Sector 7, Vidyadhar Nagar, Jaipur-302039. Jaipur RAJASTHAN
9829113330
drvikalpvashishth@gmail.com
Dr Kaushik Basu
Medical College and Hospital
Department of Orthopedics, 88 College Street, Kolkata-700073. Kolkata WEST BENGAL
9038831211
phoenix.0013@gmail.com
Dr Kiran Kumar Mukhopadhyay
Nil Ratan Sarkar Medical College and Hospital
Department of Orthopaedic Surgery, 138, Acharya Jagadish Chandra Bose Road, Kolkata-700014. Kolkata WEST BENGAL
9433166270
orthokiran@gmail.com
Dr Mohit S Kolhapure
Prakash Institute of Medical Sciences & Research (PIMS&R)
Research Room, Urun-Islampur, Islampur-Sangali Road, Islampur, Tal-Walwa, Dist-Sangali-415409. Sangli MAHARASHTRA
8888971989
mohit24365@gmail.com
Dr Varun A Bafna
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and CPR General Hospital
Department of Medicine, Dasara Chowk, Town Hall, Bhausingji Road, Kolhapur-416012. Kolhapur MAHARASHTRA
7969792775
varunbafna07@gmail.com
Dr Dattaraj Kalidas Nasnolkar
Redkar Hospital and Research Centre
Research Room, Mumbai-Goa Highway, Oxelbag, Dhargal, Tal-Pernem, Goa-403513. North Goa GOA
7969792778
nasnolkar.dattaraj@gmail.com
Dr Parag Tank
Shardaben Chimanlal Lalbhai Municipal General Hospital
Department of Orthopedics, Bhagvati Nagar, Shardaben General Hospital Road, Saraspur, Ahmedabad-380018.
Ahmadabad GUJARAT
9106633217
paragtank1@gmail.com
Dr Saurabh Khare
SMC Heart Institute and IVF Research Centre
Research Room, Infront of BSNL Office, Vidhan Sabha Road, Khamardih, Raipur-492007.
Raipur CHHATTISGARH
8103678939
Saurabhmbbs2007@gmail.com
Dr Rajesh Rana
Srirama Chandra Bhanja Medical College and Hospital
Department of Orthopaedics, Cuttack-753007. Cuttack ORISSA
9438366313
rajesh.rana66@gmail.com
Dr Azad Khan
Subharti Medical College and Hospital
Department of Orthopaedics, Subharti Puram,
NH-58, Delhi-Haridwar Bypass Road, Meerut-250005.
Meerut UTTAR PRADESH
9319837319
azd4mrt@gmail.com
Dr Rupraj Madhukar Pawar
Supe Heart & Diabetes Hospital and Research Centre
Research Room, Opp. Adhar Ashram, Near Rungtha School, Gharpure Ghat Road, Nashik-422002. Nashik MAHARASHTRA
9822060547
ruprajpawar@rediffmail.com
Dr Sachin Yadav
Swarooprani Motilal Nehru Medical College
Department of Ortho, Prayagraj-211001.
Allahabad UTTAR PRADESH
Institutional Ethics Committee, Motilal Nehru Medical College
Submittted/Under Review
Institutional Ethics Committee, Srirama Chandra Bhanja Medical College and Hospital
Submittted/Under Review
Institutional Ethics Committee, Subharti Medical College and Hospital
Submittted/Under Review
Institutional Ethics Committee, Visakha Institute of Medical Sciences (VIMS)
Approved
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College Institutional Ethics Committee 2 (RCSMGMCIEC2), Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital
Submittted/Under Review
Redkar Hospital Institutional Ethics Committee (RHIEC), Redkar Hospital and Research Centre
Shree Institutional Ethics Committee, Dhadiwal Hospital In Coalition with Shreeji Health Care, Swastik Dhadiwal Hospital
Approved
SMC Heart Institute Institutional Ethics Committee, SMC Heart Institute and IVF Research Centre
Approved
Supe Hospital Ethics Committee, Supe Heart Diabetes Hospital and Research Centre
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: M81||Osteoporosis without current pathological fracture,
Intervention / Comparator Agent
Type
Name
Details
Intervention
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 as a subcutaneous injection into periumbilical region of abdomen.
Administer initially where the patient can sit or lie down in case symptoms of orthostatic hypotension occur.
The prefilled pen delivers 30 daily doses of Abaloparatide Injection 3120 mcg/1.56 mL, each containing 80 mcg of Abaloparatide in 40 mcL.
Treatment Duration: 24 weeks
Comparator Agent
Teriparatide Injection IP 600 mcg/2.4 mL pre-filled pen
Recommended dosage is 20 mcg subcutaneously once a day.
Inject Teriparatide Injection 1 time each day in your thigh or abdomen (lower stomach area). Do not inject into a vein or a muscle.
Administer initially where the patient can sit or lie down in case symptoms of orthostatic hypotension occur.
This delivery device has enough medicine for 28 days.
Use the Teriparatide Injection cartridge for up to 28 days only.
Treatment Duration: 24 weeks
Inclusion Criteria
Age From
45.00 Year(s)
Age To
75.00 Year(s)
Gender
Female
Details
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.
ExclusionCriteria
Details
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 investigational drug within the 12 months prior to the screening period.
Lifestyle-related exclusion criteria:
23. Patients with abnormal nutritional status (abnormal diets, excessive or unusual vitamin or herbal intakes, malabsorption, significant recent weight change), Vitamin D intake of greater than or equal to 4000 IU/day (Vitamin D given during the pretreatment period to treat Vitamin D deficiency is permissible) or Vitamin A intake of greater than or equal to 10,000 IU/day.
24. Patient is known to abuse alcohol or use illegal drugs within 12 months of the screening period.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Percent change in Bone Mineral Density (BMD) at 24 weeks
Lumbar spine (L1-L4) BMD
Total hip BMD
Femoral neck BMD
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 Outcome
Outcome
TimePoints
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
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)
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 improvement
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 weeks
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.
Throughout the Study.
Serious adverse events (SAE) reported during the study.
Throughout the Study.
Changes in serum calcium levels (risk of hypercalcemia/hypocalcemia)
Total Sample Size="156" Sample Size from India="156" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
01/10/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
Postmenopausal women with osteoporosis at high risk fracture will be
screened (visit 1) within 2 to 3 weeks prior to their randomization. The
eligible patients will then be randomized to either of the 2 study groups as
per their randomization number on randomization visit (visit 3, day 1). After
randomization, patients will then be followed up on an outpatient basis with
scheduled visits at week 4 (visit 4), week 12 (visit 5), week 18 (visit 6),
week 24 (visit 7 – end of treatment visit) and week 26 (visit 8 - end of study
visit). This will be a parallel group study and all the enrolled patients will
be instructed to take the study drugs as per the prescribed regimen for a
treatment period of 24 weeks.
After confirming the inclusion/exclusion
criteria the patient will be randomized and provided with study drug at
randomization visit. Patients will be provided with a patient diary at
randomization visit, which needs to be brought along with each subsequent visit
till end of study visit. Follow-up visits will be done on week 4 / day 29±4,
week 12 / day 85±4, week 18 / day 127±4, week 24 / day 169±4 (end of treatment
visit) and week 26 / day 183±4 / end of study visit of treatment to assess efficacy,
safety and tolerability.