Clinical trial NCT04128163: Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Postmenopausal Osteoporosis
Lead sponsor: Qilu Pharmaceutical Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2019-10-16
Enrollment: 440
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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

Eligibility criteria: Inclusion Criteria:

1. Subject is willing to provide written informed consent.
2. Ambulatory woman between the age of 50 and 85 years, inclusive.
3. 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
4. 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
5. Postmenopausal defined as \>2 years postmenopausal, which can be \>2 years of spontaneous amenorrhea or \>2 years post surgical bilateral oophorectomy.

Exclusion Criteria:

1. Bone/metabolic disease:a. Any metabolic bone disease, e.g., osteomalacia or osteogenesis imperfecta,which may interfere with the interpretation of the findings.

   b. Paget's disease c. Cushing's disease d. Hyperprolactinemia
2. Current hyperparathyroidism or hypoparathyroidism by medical record
3. Thyroid condition: Hyperthyroidism or hypothyroidism.
4. Rheumatoid arthritis

   -

Primary outcomes:
measure: Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months
timeFrame: Baseline and Month 12
Secondary outcomes:
measure: Percent Change in BMD at the Lumbar Spine from Baseline up to 6 months
timeFrame: Baseline and Month 6
measure: Percent change in BMD at the total hip, femoral neck and trochanter from Baseline up to 6 months and 12 months
timeFrame: Baseline 、 Month 6 and Month 12
measure: 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
timeFrame: Baseline 、 Month 6 and Month 12
measure: Adverse events and serious adverse events
timeFrame: Baseline、 Month 1、 Month 3、 Month 6 、 Month 9 and Month 12
measure: Immunogenicity
timeFrame: Baseline、 Month 3、 Month 6 、 Month 9 and Month 12
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai sixth people's hospital
state: Shanghai
Study officials:
affiliation: Shanghai 6th People's Hospital
name: zhenlin zhang
role: PRINCIPAL_INVESTIGATOR
References: