Fragility FracturePhase 4STRONGNCT05712616
Role of Strontium Ranelate in Proximal Femur Fragility Fractures.
A Phase 4 study testing Strontium Ranelate and Lacto-N-Hexaose in people with Fragility Fracture and Femur; Fracture, Pertrochanteric, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
Trial summary
This study is being conducted with the aim of comparing the time to bone healing after surgery for fragility fractures of proximal femur between patients receiving strontium ranelate and placebo. Patients recruited are of 60 years of age and above. Read more about this study
- Who is it for?
- Ages 60 to 100 years
- Conditions the study is for
- Fragility Fracture, Femur; Fracture, Pertrochanteric, Clinical Trial
- What is being tested?
- Strontium Ranelate and Lacto-N-Hexaose
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Nov 2021to 30 Jun 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients with age =/> 60 years with proximal femur fracture including per-trochanteric, sub-trochanteric and neck of femur fractures amnebale to ORIF.
- ORIF will include hip cannulated screws, dynamic hip screw and intra-medullary nails.
Who cannot join
- Patients with metabolic bone diseases.
- Patients with pathological fractures like tumor, osteopetrosis etc.
- Patients with prior Ischemic heart diseases and underwent PCI or CABG
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
Aga Khan University Hospital
Karachi, Sindh, 74800
Dr. Marij Zahid, MSc. MBBS, +92-302-2302165, marijzh@gmail.com
About this study
Official title: Role of Strontium Ranelate in Radiological Healing of Proximal Femur Fractures. A Phase IV Double Blinded Randomized Controlled Trial
This study is being conducted with the aim of comparing the time to bone healing after surgery for fragility fractures of proximal femur between patients receiving strontium ranelate and placebo. Patients recruited are of 60 years of age and above. Bone healing will be assessed on clinical parameters when patient is able to ambulate full weight bearing without pain and on Xray images using RUSH score. Moreover Dexa scan will be performed pre-operatively and at 3 months postoperatively. The findings of this study will help in setting up guidelines for treatment of fragility proximal femur fractures in our population as there is still paucity of literature on effectiveness of strontium ranelate from our part of the world.
- Being tested
- Strontium Ranelate, Lacto-N-Hexaose
- Medical subject headings
- Fractures, Bone
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Strontium RanelateDrug
Also called placebo
Dual mode of action, anabolic and anti-resorptive
Lacto-N-HexaoseDrug
Also called Lactose
Placebo look alike drug
| Study group | Role | What they receive |
|---|---|---|
| Strontium group | Active comparator | Trial drug given in the form of sachet 2gm/sachet once every day Receives: Drug: Strontium Ranelate |
| Placebo (Lactose) | Placebo comparator | Look, smell, taste alike lactose 2gm/sachet in form of sachet Receives: Drug: Lacto-N-Hexaose |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Radiological healing on radiographs
Difference in RUSH (Radiological Healing score for hip) score measured at 12 weeks and 24 weeks
Measured: 12 weeks and 24 weeks
Secondary outcomes (1)
change Bone mineral density through DEXA scan
Difference in bone density T scores between pre-op and 3 months studies
Measured: pre-operatively or peri-admission and at 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2023
- Study start1 Nov 2021
- Primary completion30 Nov 2023 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fragility FractureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- AO Trauma Middle East and North Africa
- Responsible party
- Principal investigator, Dr. Marij Zahid, Aga Khan University Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05712616
- Sponsor's protocol ID
- 6189
- Acronym
- STRONG
- Status last verified
- Feb 2023
- First submitted
- 28 Oct 2022
- Last updated
- 3 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Strontium Ranelate in Radiological Healing of Proximal Femur Fractures. A Phase IV Double Blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05712616
- Acronym / sponsor ID
- STRONG / 6189
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Collaborators
- AO Trauma Middle East and North Africa
- Study start
- 1 Nov 2021 (actual)
- Primary completion
- 30 Nov 2023 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 3 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted with the aim of comparing the time to bone healing after surgery for fragility fractures of proximal femur between patients receiving strontium ranelate and placebo. Patients recruited are of 60 years of age and above. Bone healing will be assessed on clinical parameters when patient is able to ambulate full weight bearing without pain and on Xray images using RUSH score. Moreover Dexa scan will be performed pre-operatively and at 3 months postoperatively. The findings of this study will help in setting up guidelines for treatment of fragility proximal femur fractures in our population as there is still paucity of literature on effectiveness of strontium ranelate from our part of the world.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Strontium group | Active comparator | Drug: Strontium RanelateTrial drug given in the form of sachet 2gm/sachet once every day |
| Placebo (Lactose) | Placebo comparator | Drug: Lacto-N-HexaoseLook, smell, taste alike lactose 2gm/sachet in form of sachet |
Who may qualify
- Ages
- 60 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All patients with age =/> 60 years with proximal femur fracture including per-trochanteric, sub-trochanteric and neck of femur fractures amnebale to ORIF.
- ORIF will include hip cannulated screws, dynamic hip screw and intra-medullary nails.
Key exclusion criteria (3 listed)
- Patients with metabolic bone diseases.
- Patients with pathological fractures like tumor, osteopetrosis etc.
- Patients with prior Ischemic heart diseases and underwent PCI or CABG
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Strontium RanelateAlso: placeboDual mode of action, anabolic and anti-resorptive | Drug | Strontium group |
| Lacto-N-HexaoseAlso: LactosePlacebo look alike drug | Drug | Placebo (Lactose) |
Primary outcome
change in Radiological healing on radiographs
Time frame: 12 weeks and 24 weeks
Difference in RUSH (Radiological Healing score for hip) score measured at 12 weeks and 24 weeks
1 secondary outcome
change Bone mineral density through DEXA scan
Time frame: pre-operatively or peri-admission and at 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Fragility Fracture
RecruitingObservational study
Real World Evidence of SI-BONE's iFuse TORQ TNT Advancing Treatment of Pelvic Ring Fractures
Fracture; Pelvic, Insufficiency Fractures
Recruiting
Surgeon-Initiated Bone Health Referral Pathway in Patients Undergoing Lower Extremity Arthroplasty
Osteoporosis, Arthroplasty Complications
Not yet recruitingObservational study
Functional Outcomes in Older Adults With Fragility Fractures of the Pelvis: The FFP-France Study
Fragility Fractures of the Pelvis (FFP), Osteoporotic Fractures
RecruitingPhase 2
Essential Amino Acid Supplementation for Femoral Fragility Fractures
Femoral Fracture, Fragility Fracture
Not yet recruitingPhase 1/2
PROactive HEALing in High-Risk Pelvic and Non-hip Lower Extremity Fragility Fractures (PRO HEAL Pilot)
Lower Extremity Fractures, Pelvis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Strontium Ranelate and Lacto-N-Hexaose in people with Fragility Fracture and Femur; Fracture, Pertrochanteric, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Marij Zahid, MSc. MBBS (+92-302-2302165, marijzh@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in Radiological healing on radiographs (time frame: 12 weeks and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2023.