Osteoporosis, PostmenopausalPhase 3NCT05419427
Denosumab Biosimilar Injection in Post Menopausal Women With Osteoporosis
A Phase 3 study testing Denosumab and Denosumab-Ref in people with Osteoporosis, Postmenopausal, run by Lambda Therapeutic Research Ltd. at 1 site in India.
Trial summary
Denosumab of Intas is biosimilar denosumab candidate under development by Intas Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian drug licensing authority- Drug Controller General (India) for marketing in Indian population since 2018.As per regulatory requirement, a… Read more about this study
- Who is it for?
- Ages 55 to 90 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Denosumab and Denosumab-Ref
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 552 participants
- Where
- 1 siteIndia
- Study dates
- 11 Nov 2021to 24 Nov 2024
- Phase
- Phase 3
- 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 55 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participant must sign an ICF to participate in the study indicating that she understands the purpose of, and procedures required for the study as described in this protocol and is willing to and will be able to adhere to requirement of the protocol.
- Participant must be 55 to 90 years of age (both inclusive), at the time of signing the informed consent.
- Participants whose absolute bone mineral density T-score is less than equal to -2.5 and greater than equal -4.0 at the lumbar spine as measured by DXA (dual-energy x-ray absorptiometry), confirmed by the independent central imaging team
- At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA, confirmed by the independent central imaging team.
- Postmenopausal ambulatory female and not considered to be of child-bearing potential if:
- Women are considered post-menopausal and not of child-bearing potential if, i. They have had 12 months of natural (spontaneous) amenorrhea (no vaginal bleeding or spotting) with an appropriate clinical profile (e.g. age appropriate, history of vasomotor symptoms) OR ii. Six months of spontaneous amenorrhea with serum FSH levels greater than 40 mIU per mL OR iii. Have had surgical bilateral oophorectomy (with or without hysterectomy) at least six months ago. In the case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment if she is considered not of child-bearing potential
Who cannot join
- Documented medical history of clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Documented medical history of known allergies, hypersensitivity, or intolerance to denosumab or its excipients (refer to the IB)
- Documented medical history of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Pagets disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, rheumatoid arthritis, ankylosing spondylitis or any other joint disease limiting mobility, Cushings disease, hyperprolactinemia, malabsorption syndrome
- Contraindications to the use of denosumab or Vitamin D and Calcium as per IB/local prescribing information at screening and/or baseline
- Documented medical history and/or current evidence of any of the following oral/dental conditions
- Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
Show all 23Show fewer
- Active dental or jaw condition which requires oral surgery.
- Planned invasive dental procedure expected during study period.
- Current evidence non-healed dental or oral surgery.
- Current evidence of poor oral hygiene
- Ill-fitting denture
- Current hyper- or hypocalcemia, defined as albumin-adjusted serum calcium outside the normal range at screening.
- Current, uncontrolled hyper- or hypoparathyroidism and history of hypoparathyroidism, per participant report or chart review. PTH outside the normal range (15-65 pg/mL) as assessed by central laboratory
- Current, uncontrolled hyper- or hypothyroidism, defined as thyroid stimulating hormone outside of the normal range (TSH-0.465 to 4.68 mIU/L) at screening.
- 25 (OH) Vitamin D lower than 20 ng/mL as assessed by the central laboratory at Screening. Vitamin D repletion will be permitted, and participants may be rescreened once.
- History and /or presence of 1 severe fracture or 2 moderate vertebral fractures
- Smokers or who have smoked within last 06 months prior to start of the study.
- Administration of bisphosphonate as follows: - c. IV Bisphosphonate in the past 3 years d. Oral bisphosphonates treatment for osteoporosis i. More than 3 years of cumulative use ii. Any dose received within 6 months prior to randomization iii. More than 1 month of cumulative use between 6 and 12 months prior to randomization
- Teriparatide or any PTH analogs treatment received within 12 months prior to randomization.
- Systemic oral or transdermal estrogen, SERMs, or calcitonin treatment of more than 1 month of cumulative use within 6 months prior to randomization.
- Androgen deprivation or hormonal ablation therapy of more than 1 month of cumulative use within 6 months prior to randomization.
- Tibolone or cinacalcet treatment received within 3 months prior to randomization
- Systemic glucocorticoids: Greater than equal to 5 mg prednisone equivalent per day for more than 10 days within 3 months prior to randomization.
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
S. R. Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001
About this study
Official title: A Randomized,Double Blind,Active Controlled Parallel Arm Multicenter Study Comparing Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Denosumab of Intas Pharmaceutical Limited (60 mg/mL) With Prolia® in Postmenopausal Women With Osteoporosis
Denosumab of Intas is biosimilar denosumab candidate under development by Intas Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian drug licensing authority- Drug Controller General (India) for marketing in Indian population since 2018.As per regulatory requirement, a comparative clinical study to establish Pharmacokinetic, Pharmacodynamic and Immunogenicity equivalence is required to conclude therapeutic equivalence to obtain marketing authorization of a biosimilar investigational product. This is a multicenter, randomized, double-blind, active controlled study in approximately 552postmenopausal women with osteoporosis.
An extension of the study is planned after completion of the initial 1 year of treatment. This extension is with the objective of submitting data on safety, and Immunogenicity, after switching of Prolia treatment arm to either Prolia or Intas denosumab for 6 months. This switching data is applicable only for FDA submission. Only patients who have undergone PK assessment will be eligible for the extension phase.
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Denosumab, Denosumab-Ref
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabDrug
Also called INTP23
Denosumab 60 MG/ML
Denosumab-RefDrug
Also called Prolia
Denosumab 60 MG/ML
| Study group | Role | What they receive |
|---|---|---|
| Denosumab Solution for injection in single use prefilled syringe 60 mg permL | Experimental | Unit Dose Strength 60 mg per mL,Dosage Level 60 mg once every 6 months, Route of Administration-Subcutaneous injection Receives: Drug: Denosumab |
| Prolia® Solution for injection in single use prefilled syringe 60 mg per mL | Active comparator | Unit Dose Strength 60 mg per mL,Dosage Level 60 mg once every 6 months,Route of Administration-Subcutaneous injection Receives: Drug: Denosumab-Ref |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum measured concentration after first dose of denosumab and denosumab-ref., ,
Measured: Day 1 to Day 181
Area under the concentration versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method between denosumab and denosumab-ref postmenopausal women with osteoporosis
Measured: Day 1 to Day 181
Area under the concentration versus time curve from time zero to infinity. Where AUC 0-∞= AUC0-t + Ct2, Ct is the last measurable concentration and t2 is the terminal rate constant
Measured: Day 1 to Day 181
Secondary outcomes (2)
Maximum percent reduction from baseline Emax percent reduction from baseline serum C-terminal telopeptide (CTX) after first dose of denosumab and denosumab-ref*
Measured: Day 1 to Day 181
Area under the percent reduction from baseline versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method
Measured: Day 1 to Day 181
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2022
- Study start11 Nov 2021
- Primary completion11 Sep 2024 (estimated)
- Study completion24 Nov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Osteoporosis, PostmenopausalStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 552 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Lambda Therapeutic Research Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Intas Pharmaceutical Limited (Biopharma Division)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05419427
- Sponsor's protocol ID
- 0774-19
- Other IDs
- CTRI/2021/09/036190
- Status last verified
- Oct 2023
- First submitted
- 7 Jun 2022
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized,Double Blind,Active Controlled Parallel Arm Multicenter Study Comparing Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Denosumab of Intas Pharmaceutical Limited (60 mg/mL) With Prolia® in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT05419427
- Acronym / sponsor ID
- 0774-19
- Conditions
- Osteoporosis, Postmenopausal
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 552 participants (estimated)
- Lead sponsor
- Lambda Therapeutic Research Ltd.Industry (pharma, biotech, devices)
- Collaborators
- Intas Pharmaceutical Limited (Biopharma Division)
- Study start
- 11 Nov 2021 (actual)
- Primary completion
- 11 Sep 2024 (estimated)
- Study completion
- 24 Nov 2024 (estimated)
- First posted
- 15 Jun 2022 (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.
Denosumab of Intas is biosimilar denosumab candidate under development by Intas Pharmaceutical Limited (Biopharma Division). Denosumab of Intas is already approved by Indian drug licensing authority- Drug Controller General (India) for marketing in Indian population since 2018.As per regulatory requirement, a comparative clinical study to establish Pharmacokinetic, Pharmacodynamic and Immunogenicity equivalence is required to conclude therapeutic equivalence to obtain marketing authorization of a biosimilar investigational product. This is a multicenter, randomized, double-blind, active controlled study in approximately 552postmenopausal women with osteoporosis.
An extension of the study is planned after completion of the initial 1 year of treatment. This extension is with the objective of submitting data on safety, and Immunogenicity, after switching of Prolia treatment arm to either Prolia or Intas denosumab for 6 months. This switching data is applicable only for FDA submission. Only patients who have undergone PK assessment will be eligible for the extension phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Denosumab Solution for injection in single use prefilled syringe 60 mg permL | Experimental | Drug: DenosumabUnit Dose Strength 60 mg per mL,Dosage Level 60 mg once every 6 months, Route of Administration-Subcutaneous injection |
| Prolia® Solution for injection in single use prefilled syringe 60 mg per mL | Active comparator | Drug: Denosumab-RefUnit Dose Strength 60 mg per mL,Dosage Level 60 mg once every 6 months,Route of Administration-Subcutaneous injection |
Who may qualify
- Ages
- 55 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Participant must sign an ICF to participate in the study indicating that she understands the purpose of, and procedures required for the study as described in this protocol and is willing to and will be able to adhere to requirement of the protocol.
- Participant must be 55 to 90 years of age (both inclusive), at the time of signing the informed consent.
- Participants whose absolute bone mineral density T-score is less than equal to -2.5 and greater than equal -4.0 at the lumbar spine as measured by DXA (dual-energy x-ray absorptiometry), confirmed by the independent central imaging team
- At least two vertebrae in the L1-L4 region and at least one hip joint are evaluable by DXA, confirmed by the independent central imaging team.
- Postmenopausal ambulatory female and not considered to be of child-bearing potential if:
Key exclusion criteria (23 listed)
- Documented medical history of clinically significant cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances
- Documented medical history of known allergies, hypersensitivity, or intolerance to denosumab or its excipients (refer to the IB)
- Documented medical history of metabolic or bone disease (except osteoporosis) that may interfere with the interpretation of the results, such as Pagets disease, osteomalacia, osteogenesis imperfecta, osteopetrosis, rheumatoid arthritis, ankylosing spondylitis or any other joint disease limiting mobility, Cushings disease, hyperprolactinemia, malabsorption syndrome
- Contraindications to the use of denosumab or Vitamin D and Calcium as per IB/local prescribing information at screening and/or baseline
- Documented medical history and/or current evidence of any of the following oral/dental conditions
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 |
|---|---|---|
| DenosumabAlso: INTP23Denosumab 60 MG/ML | Drug | Denosumab Solution for injection in single use prefilled syringe 60 mg permL |
| Denosumab-RefAlso: ProliaDenosumab 60 MG/ML | Drug | Prolia® Solution for injection in single use prefilled syringe 60 mg per mL |
Primary outcome
Maximum measured concentration after first dose of denosumab and denosumab-ref., ,
Time frame: Day 1 to Day 181
Area under the concentration versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method between denosumab and denosumab-ref postmenopausal women with osteoporosis
Time frame: Day 1 to Day 181
Area under the concentration versus time curve from time zero to infinity. Where AUC 0-∞= AUC0-t + Ct2, Ct is the last measurable concentration and t2 is the terminal rate constant
Time frame: Day 1 to Day 181
2 secondary outcomes
Maximum percent reduction from baseline Emax percent reduction from baseline serum C-terminal telopeptide (CTX) after first dose of denosumab and denosumab-ref*
Time frame: Day 1 to Day 181
Area under the percent reduction from baseline versus time curve from time zero to the last measurable concentration as calculated by linear trapezoidal method
Time frame: Day 1 to Day 181
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: Undecided
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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 3 study testing Denosumab and Denosumab-Ref in people with Osteoporosis, Postmenopausal, run by Lambda Therapeutic Research Ltd. at 1 site in India.
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 6 inclusion and 23 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 13 Oct 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 India. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 Mr Prashant Modi (917940202375, prashantmodi@lambda-cro.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum measured concentration after first dose of denosumab and denosumab-ref., , (time frame: Day 1 to Day 181). The study lists 3 primary outcomes in all. 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 13 Oct 2023.