Efficacy and Safety of QL1206 in the Treatment of Postmenopausal Osteoporosis With High Fracture Risk

Qilu Pharmaceutical

Status and phase: Unknown; Phase 3

Conditions: Postmenopausal Osteoporosis

Treatments: Drug: QL1206; Drug: Placebos

Study type: Interventional

Funder types: Industry

Identifiers

NCT04128163

QL1206-004

Details and patient eligibility

About

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

Full 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

Enrollment: 440 estimated patients

Sex: Female

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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440 participants in 2 patient groups, including a placebo group

QL1206

Experimental group

Description:

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

Treatment:

Drug: QL1206

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: Placebos