UnknownPhase 3

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

China440 participantsStarted 2019-06-05

Plain-language 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

Who can participate

Age range

50 Years – 85 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. 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.

Exclusion criteria

. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percent Change in Bone Mineral Density (BMD) at the Lumbar Spine from Baseline up to 12 months

Timeframe: Baseline and Month 12

Trial details

NCT IDNCT04128163

SponsorQilu Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-08-31

Contact for this trial

shunjiang yu, CMO

0531-83129659 shunjiang.yu@qilu-pharma.com

View on ClinicalTrials.gov More Postmenopausal Osteoporosis trials