Osteoporosis, PostmenopausalPhase 3NCT05853354
Comparative Efficacy, Safety, PK, and Immunogenicity Study
A Phase 3 study testing Denosumab in people with Osteoporosis, Postmenopausal, run by Luye Pharma Group Ltd. at 39 sites in 5 countries.
Trial summary
this comparative clinical study is designed to demonstrate that LY06006 and EU-Prolia have no clinically meaningful differences in clinical efficacy, pharmacodynamic (PD), safety, PK, and immunogenicity in postmenopausal women with osteoporosis. Read more about this study
- Who is it for?
- Ages 60 to 90 years, women only
- Conditions the study is for
- Osteoporosis, Postmenopausal
- What is being tested?
- Denosumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 392 participants
- Where
- 39 sitesin 5 countries
- Study dates
- 5 Apr 2023to 30 Dec 2025
- 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 60 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age
- Participant is ≥ 60 to ≤ 90 years of age inclusive, at the time of signing the informed consent.
- Type of Participant and Disease Characteristics
- Participant is an ambulatory postmenopausal woman (defined as lack of menstrual period for at least 12 months prior to Screening Visit, for which there is no other obvious pathological or physiological cause).
- Serum FSH test can be done at the Screening Visit in case of uncertainty.
- Female participants who underwent bilateral oophorectomy (with or without hysterectomy) at least 6 weeks prior to the Screening Period are eligible to participate.
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- Participant is diagnosed with osteoporosis, with absolute BMD consistent with a T-score of ≤ -2.5 and ≥ -4.0 at the lumbar spine (L1-L4 region) as measured by DXA at the Screening Visit.
- Participant has at least two lumbar vertebrae in L1-L4 region and one hip evaluable by DXA for BMD measurement at the Screening Visit.
- Weight 5. Participant has body weight ≥ 50 kg and ≤ 90 kg at Screening. Informed Consent 6. Participant is able to read and understand, and willing to provide signed informed consent as described in Appendix 1, Section 10.1.3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- -
Who cannot join
- Medical Conditions
- Participant has a history and/or presence of any severe or more than two moderate vertebral fractures as determined by central reading of lateral spine X-ray at Screening Visit.
- Participant has a history and/or presence of hip fracture.
- Participant has a history and/or presence of atypical femur fracture.
- Participant presents with any active healing fracture, per assessment of the Investigator.
- Participant has a history of bilateral hip replacement (unilateral is allowed if the other hip is evaluable by DXA).
Show all 64Show fewer
- Participant has history and/or presence of osteonecrosis of the external auditory canal.
- Evidence of any of the following conditions which may affect BMD or interfere with the interpretation of the findings:
- Participant has a history of bone disease e.g., osteomalacia, osteopetrosis, Paget's disease, or osteogenesis imperfecta.
- Participant has a history of metabolic or other endocrinologic diseases such as Cushing's disease, hyperprolactinemia, hypopituitarism, acromegaly, malabsorption syndrome (or any gastrointestinal disorders associated with malabsorption, e.g., Crohn's disease and chronic pancreatitis).
- Participant has a history of chronic inflammatory diseases, obvious sclerosis, osteophytosis, severe scoliosis, or other degenerative changes due to other co-morbidities.
- Participant has a history or current hyperparathyroidism or hypoparathyroidism. Note: Mild non-clinically significant secondary hyperparathyroidism may be acceptable upon discussion with the Medical Monitor.
- Participant has current uncontrolled hyperthyroidism or hypothyroidism. Note: Participants with hypothyroidism who are on stable thyroid hormone replacement therapy may be allowed per the following criteria:
- If TSH level is within normal range, the participant is eligible.
- If TSH level is elevated (> 5.5 μIU/mL and ≤ 10.0 μIU/mL) and serum free T4 is within normal range, the participant is eligible. If TSH is below the lower level of normal, the participant should be excluded.
- Participant has other disease conditions where there is bone/joint involvement (e.g., rheumatoid arthritis, ankylosing spondylitis, gout, multiple myeloma, achondroplasia, bone metastases, renal osteodystrophy, osteomyelitis).
- Participant has hypocalcemia (defined as albumin adjusted serum calcium level < 2.0 mmol/L [8.0 mg/dL] Grade 2 per Common Terminology Criteria for Adverse Events version 5.0) or hypercalcemia (defined as albumin adjusted serum calcium levels > 2.62 mmol/L [10.50 mg/dL]).
- Participant has vitamin D deficiency (defined as 25-hydroxy vitamin D level < 20 ng/mL [< 50 nmol/L]).
- Note: Oral replenishment of vitamin D is permitted at the discretion of the Investigator and in accordance with local standard of care during the Screening Period. Participants can be enrolled if a repeat test (post supplementation) prior to enrollment shows corrected 25-hydroxy vitamin D level ≥ 20 ng/mL (≥ 50 nmol/L).
- Participant has any malignancy (except fully resected cutaneous basal cell or squamous cell carcinoma, cervical or breast ductal carcinoma in situ) within the last 5 years.
- Participant has known history of liver cirrhosis.
- Participant has known history of hepatitis B, hepatitis C, or HIV infection, or an active infection including, but not limited to SARS-CoV-2, tests positive for hepatitis B (positive HBsAg, positive anti-HBc with negative anti-HBs), hepatitis C (hepatitis C antibody), or HIV antibody during the Screening Period.
- Participant has oral or dental conditions:
- Prior history or current evidence of osteomyelitis or osteonecrosis of the jaw.
- Active dental or jaw condition which requires oral surgery.
- Invasive dental procedure planned during the study or within the past 6 months (e.g., tooth extraction, dental implants, oral surgery).
- Non-healed dental or oral surgery.
- Active periodontal disease.
- Poor oral hygiene.
- Participant has a history of major surgery within 8 weeks prior to the Screening Period or planned, anticipated major surgery during the study.
- Participant has a history and/or presence of significant cardiac disease or ECG abnormalities indicating significant risk for participating in the study as judged by the Investigator.
- Prior/Concomitant Therapy
- Participant shows contraindications to denosumab therapy (e.g., hypocalcemia), or calcium or vitamin D supplementation before starting study intervention administration.
- Participant requires ongoing use of any osteoporosis treatment (other than calcium and vitamin D supplements).
- Use of any of the below medications that can affect BMD:
- Denosumab used at any time prior to Screening Visit.
- Oral bisphosphonates at any dose for osteoporosis treatment:
- Used for > 3 years cumulatively at Screening Visit.
- At any dose used within 1 year prior to Screening Visit (if ≤ 3 years of use cumulatively).
- Intravenous bisphosphonate at any dose within 5 years prior to Screening Visit.
- PTH or PTH analogues at any dose within 2 years prior to Screening Visit.
- Systemic HRT (oral or transdermal estrogen), SERMs, tibolone, aromatase inhibitors, or androgens at any dose within 1 year prior to Screening Visit.
- Note: Exceptionally, non-systemic vaginal estrogen treatment is permitted.
- Calcitonin, or its derivatives, and calcimimetics (such as cinacalcet or etelcalcetide) at any dose within 12 months prior to Screening Visit.
- Calcitriol, alfacalcidol, or eldecalcitol within 3 months of the Screening Visit.
- Fluoride or strontium at any dose at any time prior to Screening Visit.
- Romosozumab or cathepsin K inhibitors received at any time prior to Screening Visit.
- Systemic glucocorticoids (≥ 5 mg prednisone or equivalent per day for more than 10 days or cumulative ≥ 50 mg) within 3 months prior to Screening Visit.
- Other bone active drugs including anticonvulsants (except benzodiazepines, gabapentin, and pregabalin), heparin (including low molecular weight heparins), vitamin K (supplementation or therapeutic dose), vitamin K antagonists (e.g., warfarin, acenocumarol), emtricitabine, tenofovir, adefovir, systemic ketoconazole, adrenocorticotropic hormone, lithium, protease inhibitors, gonadotropin-releasing hormone agonist, aluminum, barbiturate, methotrexate, chemotherapeutic agents, cyclosporine, tacrolimus, or anabolic steroids at any dose within 3 months prior to Screening Visit. Prior/Concurrent Clinical Study Experience
- Participant is receiving or has received another investigational product within 1 month or 5 half-lives of the other investigational product, whichever is longer, before study intervention administration in this study. Diagnostic Assessments
- Participant has DXA measurements where:
- Height, weight, or girth measurements may preclude accurate DXA measurements in the Investigator's opinion.
- BMD absolute value is consistent with a T-score < -4.0 at the total hip or femoral neck.
- Participant has severe renal impairment (defined as participant in dialysis or with an eGFR < 30 mL/min per MDRD formula).
- Participant has inadequate hepatic function (ALT and/or AST ≥ 2 × ULN).
- Participant presents with clinically significant leukopenia, neutropenia, or anemia as judged by the Investigator.
- Other Exclusion Criteria
- Participant has a known intolerance to calcium or vitamin D supplements.
- Participant has a history of prescription drug abuse or any illicit drug use within 6 months prior to Screening Visit.
- Participant has a history of alcohol abuse (defined as consuming more than 3 drinks on any day or more than 7 drinks per week) according to medical history within 6 months prior to Screening Visit.
- Participant is a smoker or has used nicotine and nicotine-containing products within 12 months of Screening Visit.
- Participant has a known sensitivity to mammalian cell-derived drug products.
- Participant is immunosuppressed for any reason.
- Participant has any other conditions including clinically significant medical conditions/disorders/diseases, psychiatric status, or laboratory abnormalities that in the opinion of the Investigator might interfere with the participant's ability to participate in the study, would pose a risk to the participant's safety, or interfere with the study evaluation, procedure, or completion.
Trial locations and contacts
39 sites in 5 countries.
39 sites in 5 countries
Poland19 sites
Centrum Medyczne Pratia Czestochowa
Częstochowa, 42-200
Synexus Polska Sp. z o.o.
Częstochowa, 42-202
Synexus Polska Sp. z o.o.
Gdansk, 80-382
Centrum Medyczne Pratia Gdynia
Gdynia, 81-338
Pratia Jelenia Gora
Jelenia Góra, 58-506
Synexus Polska Sp. z o.o.
Katowice, Silesian Voivodeship, 40-040
Centrum Medyczne Pratia Katowice
Katowice, 40-081
Pratia MCM Krakow
Krakow, 30-727
Krakowskie Centrum Medyczne Sp.z o.o.
Krakow, 31-501
Synexus Polska Sp. z. o.o.
Lodz, 90-127
Centrum Medyczne AMED Oddzial w Lodzi
Lodz, 91-363
Synexus Polska Sp. z o.o.
Poznan, 60-702
Centrum Medyczne Pratia Poznan
Skórzewo, Greater Poland Voivodeship, 60-185
Centrum Medyczne Pratia Poznan
Skórzewo, Greater Poland Voivodeship, 60-535
FutureMeds Warszawa Centrum
Warsaw, 00-215
Synexus Polska Sp. z o.o.
Warsaw, 02-672
Centrum Medyczne AMED
Warsaw, 7 03-291
Synexus Polska Sp. z o.o.
Wroclaw, 50-381
FutureMeds Sp. z o.o.
Wroclaw, 53-673
Japan11 sites
Nakamura Hospital
Beppu, Ôita, 874-0937
Asakawa Orthopedic Clinic
Chikugo, Hukuoka, 833-0031
Nemoto Geka SeikeiGeka
Fujimi, Saitama, 354-0021
Kobayakawa Orthopedic Rheumatologic
Fukuroi, Shizuoka, 437-0061
Gifu Prefectural General Med C.
Gifu, Gihu, 500-8717
Marunouchi Hospital
Matsumoto-shi, Nagano, 390-8601
Obase Hospital - Orthopedics
Miyako-gun, Hukuoka, 800-0344
Shimonoseki City Hospital
Shimonoseki, Yamaguchi, 750-8520
Med Teda Ooimachi Orthopaedic
Shinagawa-ku, Tôkyô, 140-0014
Koenji Orthopedic Surgery
Shinagawa-ku, Tôkyô, 166-0003
Himeno Hospital
Yame-gun, Hukuoka, 834-0115
Bulgaria4 sites
MHAT Dr. Atanas Dafovski AD
Kardzhali, 6600
Medical Centre Leo Clinic EOOD
Plovdiv, 4003
Diagnostic-consultative center Ascendent EOOD
Sofia, 1202
Medical Center Leo Clinic EOOD
Varna, 9000
United States3 sites
Valley Institute of Research
Fort Worth, Texas, 76164
Indago Research and Health Center, Inc.
Hialeah, Florida, 33012
Clinical Trials Management Services, LLC
Thousand Oaks, California, 91360
About this study
Official title: A Randomized, Double-blind, Parallel-group, Active-controlled Comparative Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of LY06006 Compared With EU-Prolia in Postmenopausal Women With Osteoporosis
this comparative clinical study is designed to demonstrate that LY06006 and EU-Prolia have no clinically meaningful differences in clinical efficacy, pharmacodynamic (PD), safety, PK, and immunogenicity in postmenopausal women with osteoporosis.
Read the detailed description
This is a randomized, double-blind, parallel-group, active-controlled, comparative study (Main Period) with a Transition Period to compare the efficacy, PD, safety, PK, and immunogenicity of LY06006 and EU-Prolia among female participants with postmenopausal osteoporosis.
Participants will go through a Screening Period within 35 days prior to first dosing. After signing the informed consent form (ICF), participants will be screened for age, menopausal status, and vitamin D levels, in addition to other inclusion/exclusion criteria. Participants will also undergo a screening DXA examination. Eligibility is based on the absolute value consistent with a T-score ≤ -2.5 and ≥ -4.0 at the lumbar spine.
Main Period Upon completing all screening assessments and meeting all eligibility criteria, participants will enter the Main Period of the study. The Main Period will last 12 months where participants will be randomized in a 1:1 ratio to receive either a dose (60 mg/1 mL) of LY06006 or EU-Prolia subcutaneously at the Baseline Visit (Day 1) and Month 6. All participants will receive daily supplements of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). Study visits will occur at the Baseline Visit (Day 1), and at Months 0.5, 1, 2, 3, 6, 9, and 12.
Follow-up BMD assessment will be done at Months 6 and 12. Blood sampling for PD, safety, PK, and immunogenicity will be done at the Baseline Visit (Day 1), and at Months 0.5, 1, 2, 3, 6, 9, and 12.
Transition Period The Transition Period will be conducted in all participants who completed the Main Period of the study. At Month 12, participants who received EU-Prolia in the Main Period will be re-randomized in a 1:1 ratio to either be transitioned to receive a dose of LY06006 or continue on EU-Prolia subcutaneously. Participants who received LY06006 in the Main Period will be re-randomized to continue to receive LY06006 in the Transition Period. All participant assignment during the Transition Period will be performed via the interactive response technology (IRT) system to maintain the blind of treatment assignment.
Blood sampling for PD, safety, PK, and immunogenicity will be done at Months 15 (PK and immunogenicity only) and 18. End of study (EoS) assessments will be performed at Month 18 or at the time of early discontinuation or withdrawal of the participant. The duration of the clinical phase for participants from the Screening Period until the EoS Visit is approximately 19 months (up to 5 weeks of Screening Period, 12 months of Main Period, and 6 months of Transition Period).
- Conditions
- Osteoporosis, Postmenopausal
- Being tested
- Denosumab
- Keywords
- Comparative efficacy;safety;PK; immunogenicity; biosimilar
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DenosumabBiological
Sterile, preservative-free, solution of denosumab packed in 1-mL pre-filled glass syringes for subcutaneous administration.Each syringe contains 60 mg denosumab (60 mg/mL solution) and is intended for single administration once every 6 months.
| Study group | Role | What they receive |
|---|---|---|
| LY06006 | Experimental | to be administered 2 doses to the patients at the main treatment period and 1 dose at the transition period. Receives: Biological: Denosumab |
| EU Prolia | Active comparator | to be administered 2 doses to the patients at the main treatment period and 1 dose at the transition period. Receives: Biological: Denosumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate equivalent efficacy between LY06006 and EU-Prolia, in terms of BMD in female participants with postmenopausal osteoporosis;
%CfB in lumbar spine BMD at Month 12
Measured: 12 months
EU Marketing Authorization only: To demonstrate similar PD between LY06006 and EU-Prolia, in terms of the bone resorption marker sCTX in female participants with postmenopausal osteoporosis
EU Marketing Authorization only: standardized AUEC0-6m (post first dose) of -%CfB in bone resorption marker sCTX over 6 months
Measured: 6 months
Secondary outcomes (1)
To provide additional comparative efficacy data of LY06006 with EU-Prolia in female participants with postmenopausal osteoporosis
- %CfB in lumbar spine BMD at Month 6
- %CfB in total hip BMD at Months 6 and 12
- %CfB in femoral neck BMD at Months 6 and 12
Measured: 6-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2023
- Study start5 Apr 2023
- Primary completion30 Jul 2025 (estimated)
- Study completion30 Dec 2025 (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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, double-blind, parallel-group, active-controlled, comparative study (Main Period) with a Transition Period to compare the efficacy, PD, safety, PK and immunogenicity of LY06006 and EU-Prolia among female participants with postmenopausal osteoporosis.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 392 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luye Pharma Group Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Joe Tai, Study chair, Luye Pharma Group Ltd.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05853354
- Sponsor's protocol ID
- LY06006/MRCT-301
- Other IDs
- IND 138591, 2022-002312-23
- Status last verified
- Apr 2024
- First submitted
- 2 May 2023
- Last updated
- 26 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Parallel-group, Active-controlled Comparative Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Immunogenicity of LY06006 Compared With EU-Prolia in Postmenopausal Women With Osteoporosis
- ClinicalTrials.gov ID
- NCT05853354
- Acronym / sponsor ID
- LY06006/MRCT-301
- Conditions
- Osteoporosis, Postmenopausal
- Keywords
- Comparative efficacy;safety;PK; immunogenicity; biosimilar
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 392 participants (estimated)
- Lead sponsor
- Luye Pharma Group Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Apr 2023 (actual)
- Primary completion
- 30 Jul 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 10 May 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 comparative clinical study is designed to demonstrate that LY06006 and EU-Prolia have no clinically meaningful differences in clinical efficacy, pharmacodynamic (PD), safety, PK, and immunogenicity in postmenopausal women with osteoporosis.
Detailed description
This is a randomized, double-blind, parallel-group, active-controlled, comparative study (Main Period) with a Transition Period to compare the efficacy, PD, safety, PK, and immunogenicity of LY06006 and EU-Prolia among female participants with postmenopausal osteoporosis.
Participants will go through a Screening Period within 35 days prior to first dosing. After signing the informed consent form (ICF), participants will be screened for age, menopausal status, and vitamin D levels, in addition to other inclusion/exclusion criteria. Participants will also undergo a screening DXA examination. Eligibility is based on the absolute value consistent with a T-score ≤ -2.5 and ≥ -4.0 at the lumbar spine.
Main Period Upon completing all screening assessments and meeting all eligibility criteria, participants will enter the Main Period of the study. The Main Period will last 12 months where participants will be randomized in a 1:1 ratio to receive either a dose (60 mg/1 mL) of LY06006 or EU-Prolia subcutaneously at the Baseline Visit (Day 1) and Month 6. All participants will receive daily supplements of elemental calcium (at least 1000 mg) and vitamin D (at least 400 IU). Study visits will occur at the Baseline Visit (Day 1), and at Months 0.5, 1, 2, 3, 6, 9, and 12.
Follow-up BMD assessment will be done at Months 6 and 12. Blood sampling for PD, safety, PK, and immunogenicity will be done at the Baseline Visit (Day 1), and at Months 0.5, 1, 2, 3, 6, 9, and 12.
Transition Period The Transition Period will be conducted in all participants who completed the Main Period of the study. At Month 12, participants who received EU-Prolia in the Main Period will be re-randomized in a 1:1 ratio to either be transitioned to receive a dose of LY06006 or continue on EU-Prolia subcutaneously. Participants who received LY06006 in the Main Period will be re-randomized to continue to receive LY06006 in the Transition Period. All participant assignment during the Transition Period will be performed via the interactive response technology (IRT) system to maintain the blind of treatment assignment.
Blood sampling for PD, safety, PK, and immunogenicity will be done at Months 15 (PK and immunogenicity only) and 18. End of study (EoS) assessments will be performed at Month 18 or at the time of early discontinuation or withdrawal of the participant. The duration of the clinical phase for participants from the Screening Period until the EoS Visit is approximately 19 months (up to 5 weeks of Screening Period, 12 months of Main Period, and 6 months of Transition Period).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- This is a randomized, double-blind, parallel-group, active-controlled, comparative study (Main Period) with a Transition Period to compare the efficacy, PD, safety, PK and immunogenicity of LY06006 and EU-Prolia among female participants with postmenopausal osteoporosis.
| Arm | Type | Receives |
|---|---|---|
| LY06006 | Experimental | Biological: Denosumabto be administered 2 doses to the patients at the main treatment period and 1 dose at the transition period. |
| EU Prolia | Active comparator | Biological: Denosumabto be administered 2 doses to the patients at the main treatment period and 1 dose at the transition period. |
Who may qualify
- Ages
- 60 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age
- Participant is ≥ 60 to ≤ 90 years of age inclusive, at the time of signing the informed consent.
- Type of Participant and Disease Characteristics
- Participant is an ambulatory postmenopausal woman (defined as lack of menstrual period for at least 12 months prior to Screening Visit, for which there is no other obvious pathological or physiological cause).
- Participant is diagnosed with osteoporosis, with absolute BMD consistent with a T-score of ≤ -2.5 and ≥ -4.0 at the lumbar spine (L1-L4 region) as measured by DXA at the Screening Visit.
Key exclusion criteria (64 listed)
- Medical Conditions
- Participant has a history and/or presence of any severe or more than two moderate vertebral fractures as determined by central reading of lateral spine X-ray at Screening Visit.
- Participant has a history and/or presence of hip fracture.
- Participant has a history and/or presence of atypical femur fracture.
- Participant presents with any active healing fracture, per assessment of the Investigator.
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 |
|---|---|---|
| DenosumabSterile, preservative-free, solution of denosumab packed in 1-mL pre-filled glass syringes for subcutaneous administration.Each syringe contains 60 mg denosumab (60 mg/mL solution) and is intended for single administration once every 6 months. | Biological | EU Prolia, LY06006 |
Primary outcome
To demonstrate equivalent efficacy between LY06006 and EU-Prolia, in terms of BMD in female participants with postmenopausal osteoporosis;
Time frame: 12 months
%CfB in lumbar spine BMD at Month 12
EU Marketing Authorization only: To demonstrate similar PD between LY06006 and EU-Prolia, in terms of the bone resorption marker sCTX in female participants with postmenopausal osteoporosis
Time frame: 6 months
EU Marketing Authorization only: standardized AUEC0-6m (post first dose) of -%CfB in bone resorption marker sCTX over 6 months
1 secondary outcome
To provide additional comparative efficacy data of LY06006 with EU-Prolia in female participants with postmenopausal osteoporosis
Time frame: 6-12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2024.
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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.
Joe Tai study chair
Luye Pharma Group Ltd.
39 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Denosumab in people with Osteoporosis, Postmenopausal, run by Luye Pharma Group Ltd. at 39 sites in 5 countries.
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 10 inclusion and 64 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 26 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 39 sites in Poland, Japan, Bulgaria, United States, Czechia. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To demonstrate equivalent efficacy between LY06006 and EU-Prolia, in terms of BMD in female participants with postmenopausal osteoporosis; (time frame: 12 months). The study lists 2 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 26 Apr 2024.