Postmenopausal OsteoporosisPhase 3NCT04128163
Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk
A Phase 3 study testing QL1206 in people with Postmenopausal Osteoporosis, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
A randomized, double-blind, two-group parallel, placebo-controlled clinical Phase III trial to compare the efficacy and safety of QL1206 and placebo in postmenopausal women with osteoporosis at high risk of fracture Read more about this study
- Who is it for?
- Ages 50 to 85 years, women only
- Conditions the study is for
- Postmenopausal Osteoporosis
- What is being tested?
- QL1206
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 440 participants
- Where
- 1 siteChina
- Study dates
- 5 Jun 2019to 1 Dec 2021
- 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 50 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is willing to provide written informed consent.
- Ambulatory woman between the age of 50 and 85 years, inclusive.
- The subject has a BMD absolute value consistent with a T-score<-2.5 and >-4.0 at either the lumbar spine or total hip
- All subjects must have at least one of following additional the risk factors:history of fracture（after 40 years）,parental history of hip fracture, low Body mass index (BMI≤19kg/m^2), elderly (age≥65year)，current smoker
- Postmenopausal defined as >2 years postmenopausal, which can be >2 years of spontaneous amenorrhea or >2 years post surgical bilateral oophorectomy.
Who cannot join
- Bone/metabolic disease:a. Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,which may interfere with the interpretation of the findings.
- Paget's disease c. Cushing's disease d. Hyperprolactinemia
- Current hyperparathyroidism or hypoparathyroidism by medical record
- Thyroid condition: Hyperthyroidism or hypothyroidism.
- Rheumatoid arthritis
- -
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai sixth people's hospital
Shanghai, Shanghai Municipality
zhenlin zhang
zhenlin zhang
About this study
Official title: A Twelve-month Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of QL1206 in Chinese Postmenopausal Women With Osteoporosis at High Risk of Fracture
A randomized, double-blind, two-group parallel, placebo-controlled clinical Phase III trial to compare the efficacy and safety of QL1206 and placebo in postmenopausal women with osteoporosis at high risk of fracture
Read the detailed description
This is a randomized, double-blind, two-group parallel, placebo-controlled clinical Phase III trial.
The primary objective is to evaluate the effect of QL1206 treatment compared with placebo in Chinese postmenopausal women with osteoporosis at high risk of fracture.
The secondary objective is to evaluate the clinical safety, immunogenicity and pharmacokinetic (PK) characteristics of QL1206 in women with osteoporosis at high risk of postmenopausal fracture
The exploratory purpose is to evaluate the effect of ADA on the characteristics of QL1206 PK and the relationship between QL1206 exposure and pharmacodynamic endpoints, efficacy and adverse events
Subjects would sequentially enrolled according to the protocol in one of two cohorts.Subjects would receive a single 60mg of QL1206 or placebo every 6 month for1 year(twice for one, subcutaneous injection) ,meanwhile taking 500 mg of calcium and 1000IU of vitamin D daily
- Conditions
- Postmenopausal Osteoporosis
- Being tested
- QL1206, Placebos
- Medical subject headings
- Osteoporosis, Postmenopausal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QL1206Drug
Also called Recombinant anti-RANKL human monoclonal antibody injection
subcutaneous injection of 60 mg（60mg:1ml）, Q6M, twice for one year.
Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU
PlacebosDrug
subcutaneous injection of（1ml）, Q6M, twice for one year.
Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU
| Study group | Role | What they receive |
|---|---|---|
| QL1206 | Experimental | QL1206 injection (60mg:1ml) by subcutaneous injectionevery 6 month for two times.
Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU Receives: Drug: QL1206 |
| Placebo | Placebo comparator | placebo injection (1ml) by subcutaneous injectionevery 6 month for two times.
Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months
Bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD scan was done using dual energy x-ray absorptiometry (DXA). It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calcuated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. The analysis was performed by Analysis of Covariance (ANCOVA) model adjusted for treatment, region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as Baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the Last Observation Carried Forward (LOCF), provided the assessment was taken on or after at least three month on-therapy.
Measured: Baseline and Month 12
Secondary outcomes (5)
Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months
BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value
Measured: Baseline and Month 6
Percent change in BMD at the total hip, femoral neck and trochanter from Baseline up to 6 months and 12 months
Percent change in BMD at the total hip, femoral neck and trochanter as measured BMD is the amount of bone mineral in bone tissue. BMD scan was done using DXA. It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calculated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value.
Measured: Baseline 、 Month 6 and Month 12
Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type I N Propeptideserum (s-PINP) from Baseline up to 6 months and 12 months
s-CTX is biomarker of bone resorption and formation. s-CTX was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100.
s-PINP is biomarker of bone resorption and formation. s-PINP was assessed during Screening, Month 6 and Month 12 in the Double-blind Treatment Phase. The value during Screening was considered as the Baseline value. Percent change from Baseline was assessed as the value at the indicated visit minus the Baseline value divided by the Baseline value x 100
Measured: Baseline 、 Month 6 and Month 12
Adverse events and serious adverse events
Evaluation of the follwing parameters. Including adverse events(AEs), change in physical examination findings, change in vital signs, clinical laboratory testing for systemic safety,including liver function,renal function ,compelete blood count,and clinical chemistries
Measured: Baseline、 Month 1、 Month 3、 Month 6 、 Month 9 and Month 12
Immunogenicity
Anti-denosumab antibody formation was assessed. Binding antibody and neutralizing antibody assays were used to assess number of participants with anti-denosumab antibody.
Measured: Baseline、 Month 3、 Month 6 、 Month 9 and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2019
- Study start5 Jun 2019
- Primary completion31 Aug 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postmenopausal OsteoporosisStudies of the same condition, open and under way.
- More trials run by Qilu Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 440 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- zhenlin zhang, Principal investigator, Shanghai 6th People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04128163
- Sponsor's protocol ID
- QL1206-004
- Status last verified
- Sep 2019
- First submitted
- 25 Sep 2019
- Last updated
- 6 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Twelve-month Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of QL1206 in Chinese Postmenopausal Women With Osteoporosis at High Risk of Fracture
- ClinicalTrials.gov ID
- NCT04128163
- Acronym / sponsor ID
- QL1206-004
- Conditions
- Postmenopausal Osteoporosis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 440 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Jun 2019 (actual)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 16 Oct 2019 (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.
A randomized, double-blind, two-group parallel, placebo-controlled clinical Phase III trial to compare the efficacy and safety of QL1206 and placebo in postmenopausal women with osteoporosis at high risk of fracture
Detailed description
This is a randomized, double-blind, two-group parallel, placebo-controlled clinical Phase III trial.
The primary objective is to evaluate the effect of QL1206 treatment compared with placebo in Chinese postmenopausal women with osteoporosis at high risk of fracture.
The secondary objective is to evaluate the clinical safety, immunogenicity and pharmacokinetic (PK) characteristics of QL1206 in women with osteoporosis at high risk of postmenopausal fracture
The exploratory purpose is to evaluate the effect of ADA on the characteristics of QL1206 PK and the relationship between QL1206 exposure and pharmacodynamic endpoints, efficacy and adverse events
Subjects would sequentially enrolled according to the protocol in one of two cohorts.Subjects would receive a single 60mg of QL1206 or placebo every 6 month for1 year(twice for one, subcutaneous injection) ,meanwhile taking 500 mg of calcium and 1000IU of vitamin D daily
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| QL1206 | Experimental | Drug: QL1206QL1206 injection (60mg:1ml) by subcutaneous injectionevery 6 month for two times. Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU |
| Placebo | Placebo comparator | Drug: Placebosplacebo injection (1ml) by subcutaneous injectionevery 6 month for two times. Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is willing to provide written informed consent.
- Ambulatory woman between the age of 50 and 85 years, inclusive.
- The subject has a BMD absolute value consistent with a T-score<-2.5 and >-4.0 at either the lumbar spine or total hip
- All subjects must have at least one of following additional the risk factors:history of fracture（after 40 years）,parental history of hip fracture, low Body mass index (BMI≤19kg/m^2), elderly (age≥65year)，current smoker
- Postmenopausal defined as >2 years postmenopausal, which can be >2 years of spontaneous amenorrhea or >2 years post surgical bilateral oophorectomy.
Key exclusion criteria (6 listed)
- Bone/metabolic disease:a. Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,which may interfere with the interpretation of the findings.
- Current hyperparathyroidism or hypoparathyroidism by medical record
- Thyroid condition: Hyperthyroidism or hypothyroidism.
- Rheumatoid arthritis
- -
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 |
|---|---|---|
| QL1206Also: Recombinant anti-RANKL human monoclonal antibody injectionsubcutaneous injection of 60 mg（60mg:1ml）, Q6M, twice for one year. Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU | Drug | QL1206 |
| Placebossubcutaneous injection of（1ml）, Q6M, twice for one year. Dietary Supplement: Elemental Calcium Oral, at least 500 mg Dietary Supplement: Vitamin D Oral, 1000 IU | Drug | Placebo |
Primary outcome
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months
Time frame: Baseline and Month 12
Bone mineral density (BMD) is the amount of bone mineral in bone tissue. BMD scan was done using dual energy x-ray absorptiometry (DXA). It is used to identify osteoporosis, determine risk for fractures, and measure response to osteoporosis treatment. The percentage change from Baseline for BMD was calcuated as the value at the indicated time point minus the Baseline value multiplied by 100 and divided by the Baseline value. The analysis was performed by Analysis of Covariance (ANCOVA) model adjusted for treatment, region and Baseline BMD for the skeletal site under consideration as a continuous covariate for assessment. Region and treatment by region interaction was included in the model. Screening visit was considered as Baseline for BMD. For participants who withdrew early, the missing BMD assessments was estimated by the Last Observation Carried Forward (LOCF), provided the assessment was taken on or after at least three month on-therapy.
5 secondary outcomes
Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months
Time frame: Baseline and Month 6
Percent change in BMD at the total hip, femoral neck and trochanter from Baseline up to 6 months and 12 months
Time frame: Baseline 、 Month 6 and Month 12
Percent Change in Serum Carboxy-terminal Cross-linking Telopeptide of Type I Collagen (s-CTX) and Serum Procollagen Type I N Propeptideserum (s-PINP) from Baseline up to 6 months and 12 months
Time frame: Baseline 、 Month 6 and Month 12
Adverse events and serious adverse events
Time frame: Baseline、 Month 1、 Month 3、 Month 6 、 Month 9 and Month 12
Immunogenicity
Time frame: Baseline、 Month 3、 Month 6 、 Month 9 and Month 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2019.
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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.
zhenlin zhang principal investigator
Shanghai 6th People's Hospital
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 QL1206 in people with Postmenopausal Osteoporosis, run by Qilu Pharmaceutical Co., Ltd. at 1 site in China.
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 5 inclusion and 6 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 6 Nov 2019. 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 China. 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 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 shunjiang yu, CMO (0531-83129659, shunjiang.yu@qilu-pharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months (time frame: Baseline and Month 12). 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 6 Nov 2019.