A Phase 3 interventional study of Quan Duzhong Capsules and Quan Duzhong Capsule Placebo in Primary Osteoporosis, sponsored by Shanghai University of Traditional Chinese Medicine. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-26.
Sponsored by Shanghai University of Traditional Chinese Medicine · Phase 3, Interventional, and Treatment
The goal of this clinical trial is to learn if Quan Duzhong Capsules work to treat primary osteoporosis in adults. It will also learn about the safety of Quan Duzhong Capsules. The main questions it aims to answer are:
Do Quan Duzhong Capsules improve bone mineral density (BMD) of the lumbar spine (L1-L4) after 6 months of treatment?
Do Quan Duzhong Capsules change muscle strength, the number of falls, and bone metabolism markers?
What medical problems do participants have when taking Quan Duzhong Capsules?
Researchers will compare Quan Duzhong Capsules to a placebo (a look-alike substance that contains no drug) to see if Quan Duzhong Capsules work to treat primary osteoporosis. Both groups will also take a calcium and vitamin D3 preparation.
Participants will:
Take Quan Duzhong Capsules or a placebo 3 capsules twice daily after meals, plus 1 calcium and vitamin D3 tablet once daily 10 minutes after dinner, for 6 months
Visit the clinic at baseline and after 6 months for checkups and tests, including bone mineral density (DXA) scans and blood tests for bone metabolism, calcium and phosphorus metabolism, liver and kidney function
Report any falls, symptoms, and medical problems during the study
1,601 studies on the registry are indexed under Osteoporosis; 209 are open to participants now.
This study's planned enrollment of 300 is above the median of 88 across 1,084 interventional studies indexed under Osteoporosis.
Browse Osteoporosis studies →Shanghai University of Traditional Chinese Medicine is the lead sponsor of 102 studies on the registry; 20 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Quan Duzhong Capsules (Du-Zhong) are administered orally, 3 capsules per dose, twice daily, taken with warm water after meals, for 6 consecutive months. All participants also receive a calcium and vitamin D3 preparation (Liquan Calcium Carbonate and Vitamin D3 Tablets, each tablet containing calcium 600 mg and vitamin D3 125 IU), oral administration, 1 tablet per dose, once daily, taken with warm water 10 minutes after dinner, for 6 consecutive months.
Drug: Quan Duzhong Capsules
Quan Duzhong Capsule placebo, oral, 3 capsules twice daily after meals, plus Calcium Carbonate and Vitamin D3 Tablets, oral, 1 tablet once daily 10 minutes after dinner, for 6 consecutive months.
Drug: Quan Duzhong Capsule Placebo
Quan Duzhong Capsules (Du-Zhong, Eucommia ulmoides capsules), oral administration, 3 capsules per dose, twice daily, taken with warm water after meals, for 6 consecutive months. All participants also receive a calcium and vitamin D3 preparation (Liquan Calcium Carbonate and Vitamin D3 Tablets, each tablet containing calcium 600 mg and vitamin D3 125 IU), oral administration, 1 tablet per dose, once daily, taken with warm water 10 minutes after dinner, for 6 consecutive months.
Also known as: Du-Zhong Capsules
Quan Duzhong Capsule placebo is a look-alike substance that contains no active drug. It is manufactured to match Quan Duzhong Capsules in color, odor, taste, shape, and texture. It is administered orally, 3 capsules per dose, twice daily, taken with warm water after meals, for 6 consecutive months. All participants also receive a calcium and vitamin D3 preparation (Liquan Calcium Carbonate and Vitamin D3 Tablets, each tablet containing calcium 600 mg and vitamin D3 125 IU), oral administration, 1 tablet per dose, once daily, taken with warm water 10 minutes after dinner, for 6 consecutive months.
Change in bone mineral density (BMD) of the lumbar spine (L1-L4)
BMD of the lumbar spine (L1-L4) measured by dual-energy X-ray absorptiometry (DXA). The absolute change and percentage change from baseline will be calculated.
Time frame: Baseline and 6 months
Change in Serum Calcium
Serum calcium measured by laboratory tests. Change from baseline will be calculated.
Time frame: Baseline and 6 months
Change in Serum Phosphorus
Serum phosphorus measured by laboratory tests. Change from baseline will be calculated.
Time frame: Baseline and 6 months
Change in muscle strength
Muscle strength is assessed by study-specific measurements during the study.
Time frame: Baseline and 6 months
Change in incidence of falls
the number and incidence of falls should be recorded during the study.
Time frame: Baseline and 6 months
Change in 25-Hydroxyvitamin D
Serum 25-hydroxyvitamin D measured by laboratory tests. Change from baseline will be calculated.
Time frame: Baseline and 6 months
Change in Parathyroid Hormone (PTH)
Serum parathyroid hormone (PTH) measured by laboratory tests. Change from baseline will be calculated.
Time frame: Baseline and 6 months
Change in Serum P1NP
Serum procollagen type 1 N-terminal propeptide (P1NP), a bone formation marker, measured by laboratory tests. Change from baseline will be calculated.
Time frame: Baseline and 6 months
Change in Serum CTX
Serum C-terminal telopeptide of type I collagen (CTX), a bone resorption marker, measured by laboratory tests. Change from baseline will be calculated.
Time frame: Baseline and 6 months
Change in Serum Osteocalcin
Serum osteocalcin measured by laboratory tests. Change from baseline will be calculated.
Time frame: Baseline and 6 months
Change in Bone Mineral Density (BMD) of the Femoral Neck and Total Hip
BMD of the femoral neck and total hip measured by dual-energy X-ray absorptiometry (DXA). Change from baseline will be calculated for each site.
Time frame: Baseline and 6 months
Change in T-score at the Femoral Neck and Total Hip
T-score at the femoral neck and total hip measured by DXA. Change from baseline will be calculated for each site.
Time frame: Baseline and 6 months
Plan to share: Yes — De-identified individual participant data (including data dictionaries) will be shared with researchers who provide a methodologically sound proposal. The data will be available for secondary analyses aimed at achieving the aims in the approved proposal.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be available beginning 3 months and ending 5 years after article publication.
Access criteria: Researchers should submit a data access request to the study contact. Requests will be reviewed by the study steering committee. A signed Data Sharing Agreement must be in place before data access is granted.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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