| CTRI Number |
CTRI/2012/10/003078 [Registered on: 29/10/2012] Trial Registered Prospectively |
| Last Modified On: |
11/04/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
Public Title of Study
Modification(s)
|
To study the effect and safety of drug product Romosozumab in Postmenopausal Women With Osteoporosis. |
Scientific Title of Study
Modification(s)
|
A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of Romosozumab Treatment in Postmenopausal Women With Osteoporosis |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 20070337 - Protocol amendment 4 dated 18 September 2013 |
Protocol Number |
| NCT01575834 |
ClinicalTrials.gov |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
|
| Affiliation |
|
| Address |
|
| Phone |
|
| Fax |
|
| Email |
|
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Axel Bortels |
| Designation |
Regional Clinical Trial Manager |
| Affiliation |
Amgen N.V |
| Address |
Amgen N.V. Arianelaan 5,
1200 Brussels, Belgium
1200
Other |
| Phone |
3227752792 |
| Fax |
3227752782 |
| Email |
abortels@amgen.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Veena Jaguste |
| Designation |
Dir Development Operations |
| Affiliation |
Amgen Technology Pvt. Ltd |
| Address |
A Wing, Level 4, Dynasty Business Park, A.K Road, Andheri (East) Mumbai - India
MAHARASHTRA
400059
India |
| Phone |
912267869353 |
| Fax |
|
| Email |
vjaguste@amgen.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Amgen Technology Pvt Ltd |
| Address |
A Wing, Level 4, Dynasty Business Park, A.K Road, Andheri (East) Mumbai - 400059 | India |
| Type of Sponsor |
Other [Global Biotech Company ] |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
Argentina
Australia
Belgium
Brazil
Canada
Czech Republic
Denmark
Estonia
Germany
Hungary
India
Japan
Latvia
Lithuania
Mexico
New Zealand
Poland
Romania
Spain
Switzerland
United Kingdom
United States of America
Dominican Republic
Hong Kong
Colombia |
Sites of Study
Modification(s)
|
| No of Sites = 6 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Usha Sriram |
ACEER Health private Limited,Chennai |
7 /12, 15th Cross street,
Sastri Nagar,Adyar,
Chennai - 600 020
Tamil Nadu, India
Chennai
TAMIL NADU |
9840019905
drushasriram@gmail.com |
| Dr Thomas Paul |
Christian Medical College, Vellore |
Dept of Endocrinology, Diabetes and Medicine
Vellore – 632004.
Tamil Nadu, India
Vellore
TAMIL NADU |
9566920379
thomasvpaul@yahoo.com |
| Dr Naresh Shetty |
M.S. Ramaiah Medical College & Hospital,Bangalore |
New BEL road, MSRIT post,
Bangalore – 560054
Karnataka, India
Bangalore
KARNATAKA |
9844050222
naresh8@hotmail.com |
| Dr Parag Sancheti |
Sancheti Institute of Orthopaedics and Rehabilitation, Pune |
16, Shivajinagar,
Pune-411005,
Maharashtra, India
Pune
MAHARASHTRA |
9822353333
parag@sanchetihospital.com |
| Dr Tushar Bandgar |
Seth G.S Medical college & K.E.M. hospital, Mumbai |
DXA room, ward no 32, 9th floor, new building, Parel,
Mumbai - 400 012,
Maharashtra, India
Mumbai
MAHARASHTRA |
9820025037
drtusharb@gmail.com |
| Dr Ritesh Kumar Agarwal |
Somani hospital, Jaipur |
Shri Gopal nagar, Gopalpura bypass
Jaipur - 302 019
Rajasthan, India
Jaipur
RAJASTHAN |
9799560903
riteshagarwaldr@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 6 |
| Name of Committee |
Approval Status |
| Christian Medical College, Vellore |
Approved |
| M.S. Ramaiah Medical College & Hospital, IEC |
Approved |
| National Ethics Committee,Chennai |
Approved |
| Sancheti Institute of Orthopaedics and Rehabilitation, IEC, Pune |
Approved |
| Seth G.S Medical college & K.E.M. hospital, IEC, Mumbai |
Approved |
| Somex Research Committee, IEC, Jaipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M810||Age-related osteoporosis without current pathological fracture, Postmenopausal Osteoporosis
, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Intervention |
Experimental: Active Treatment
sub-cutaneous AMG 785 injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 24 months |
Drug: AMG 785
sub-cutaneous AMG 785 injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 24 months |
| Comparator Agent |
Placebo Comparator: Placebo
sub-cutaneous placebo injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 24 months |
Drug: Placebo
sub-cutaneous placebo injections for 12 months, followed by sub-cutaneous open-label denosumab injections for another 24 months
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
55.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Female |
| Details |
Postmenopausal women osteoporosis, defined as low bone mineral density
|
|
| ExclusionCriteria |
| Details |
Severe osteoporosis
Use of agents affecting bone metabolism
History of metabolic or bone disease (except osteoporosis)
Vitamin D insufficiency (vitamin D repletion and rescreening is permitted)
Current hyper- or hypocalcemia
Current, uncontrolled hyper or hypothyroidism
Current, uncontrolled hyper or hypoparathyroidism |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Incidence of vertebral fracture |
[ Time Frame: 12 Months, 24 Months ] [ Designated as safety issue: No ]
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Incidence of Fracture |
[ Time Frame: 12 Months ] [ Designated as safety issue: No ]
|
| Changes In Bone Mineral Density from Baseline to 12 Months |
[ Time Frame: 12 Months ] [ Designated as safety issue: No ]
|
| Changes In Bone Mineral Density from Baseline to 24 Months |
[ Time Frame: 24 Months ] [ Designated as safety issue: No ]
|
|
Target Sample Size
Modification(s)
|
Total Sample Size="6600"
Sample Size from India="106"
Final Enrollment numbers achieved (Total)= "7180"
Final Enrollment numbers achieved (India)="106" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
31/10/2012 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
01/03/2012 |
| Date of Study Completion (Global) |
Date Missing |
Estimated Duration of Trial
Modification(s)
|
Years="4"
Months="2"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
1. Pub-Id-066796
2. Pub-Id-064501
3. Pub-Id-066187
4. Pub-Id-066188
5. Pub-Id-066741
6. Pub-Id-066742
7. Pub-Id-066743
8. Pub-Id-066797
9. Pub-Id-066851
10. Pub-Id-067909
11. Pub-Id-068466
12. Pub-Id-071316
13. Pub-Id-069108
14. Pub-Id-069239
15. Pub-Id-069305
16. Pub-Id-069413
17. Pub-Id-069414
18. Pub-Id-069415
19. Pub-Id-070245
20. Pub-Id-070323
21. Pub-Id-072471
22. Pub-Id-072473
23. Pub-Id-072500
24. Pub-Id-074189
25. Pub-Id-074190
26. Pub-Id-070941
27. Cosman F, et al. N Engl J Med. 2016;375(16):1532-1543
28. Pub-Id-060375
29. Pub-Id-063632
30. Pub-Id-064280
31. Pub-Id-064414
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
A Multicenter, International, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy and Safety of AMG 785 Treatment in Postmenopausal Women With Osteoporosis. The purpose of this study is to determine if treatment is effective in preventing fractures in women with postmenopausal osteoporosis
A total of 7180 subjects were randomized to the romosozumab 210 mg QM (3589 subjects) and placebo (3591 subjects) groups. Of the 7180 randomized subjects, 6045 completed the 24-month study period and entered the 12-month extension period. Of the 7180 randomized subjects, 80% of the subjects completed the 36-month study period (romosozumab/denosumab, 79.4%; placebo/denosumab, 80.5%). Throughout the study, withdrawn consent was the most frequently reported reason for discontinuation from study in both treatment groups (romosozumab/denosumab, 10.9%; placebo/denosumab, 9.8%). Overall during the 36-month study period, 79.0% of subjects completed investigational product administration (romosozumab/denosumab, 78.2%; placebo/denosumab, 79.8%). Throughout the study, withdrawn consent was the most frequently reported reason for discontinuation of investigational product (romosozumab/denosumab, 9.9%; placebo/denosumab, 8.8%).
|