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

NCT ID: NCT04128163

Last Updated: 2019-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-05
• Study Completion Date: 2021-12-01

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

Conditions

Postmenopausal Osteoporosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

QL1206

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

Group Type: EXPERIMENTAL

QL1206

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

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

Interventions

QL1206

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

Intervention Type: DRUG

Placebos

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

Intervention Type: DRUG

Other Intervention Names

Recombinant anti-RANKL human monoclonal antibody injection

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

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• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Qilu Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

zhenlin zhang

Role: PRINCIPAL_INVESTIGATOR

Shanghai 6th People's Hospital

Locations

Shanghai sixth people's hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

shunjiang yu, CMO

Role: CONTACT

shunjiang.yu@qilu-pharma.com

0531-83129659

Facility Contacts

zhenlin zhang

Role: primary

Other Identifiers

QL1206-004

Identifier Type: -

Identifier Source: org_study_id