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Primary OsteoporosisPhase 3QZDC-PONCT07895082

Quanduzhong Capsules for Primary Osteoporosis

A Phase 3 study testing Quan Duzhong Capsules in people with Primary Osteoporosis, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Primary Osteoporosis
What is being tested?
Quan Duzhong Capsules
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
300 participants
Where
1 siteChina
Study dates
15 Oct 2026to 1 May 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Postmenopausal women aged 45-80 years (inclusive) or men aged 50-80 years (inclusive).
  • T-score ≤ -2.50 and ≥ -3 at the axial skeleton (lumbar spine L1-L4, femoral neck, or total hip).
  • Participants voluntarily participate in this study and provide written informed consent.

Who cannot join

  • History of hip fracture.
  • Use of any of the following medications affecting bone metabolism:
  • Intravenous bisphosphonates within 5 years before enrollment.
  • Oral bisphosphonates meeting any of the following conditions: prior cumulative use of ≥3 years; any use within 6 months before enrollment; or cumulative use exceeding 1 month within 12 months before enrollment.
  • History of denosumab use within 18 months before enrollment.
  • History of teriparatide or other parathyroid hormone (PTH) analog use within 12 months before enrollment.
Show all 23Show fewer
  • Oral or transdermal use of estrogen, progestin, selective estrogen receptor modulators (raloxifene), or calcitonin with cumulative use exceeding 1 month within 6 months before enrollment.
  • Androgen deprivation therapy or hormonal ablation therapy with cumulative treatment exceeding 1 month within 6 months before enrollment.
  • History of tibolone or cinacalcet use within 3 months before enrollment.
  • History of systemic glucocorticoid use at ≥5 mg prednisone equivalent per day for more than 10 consecutive days within 3 months before enrollment.
  • Presence of metabolic diseases or bone diseases that significantly affect bone metabolism (other than osteoporosis), such as Paget's disease of bone, osteomalacia, rheumatoid arthritis, gout, multiple myeloma, osteogenesis imperfecta, ankylosing spondylitis, Cushing's disease, and malabsorption syndrome.
  • History of organ transplantation or bone marrow transplantation.
  • History of osteonecrosis of the jaw.
  • Active malignancy within the past 2 years (except skin cancer).
  • Known hypersensitivity to calcium and vitamin D preparations or the investigational traditional Chinese medicine preparation(s).
  • History of taking Quan Duzhong Capsules within the past 6 months.
  • Severe vitamin D deficiency (serum 25-hydroxyvitamin D < 25 nmol/L [10 ng/mL]).
  • Hypercalcemia or hypocalcemia.
  • Uncontrolled hypothyroidism or hyperthyroidism (TSH outside the normal range).
  • Uncontrolled hypoparathyroidism or hyperparathyroidism (PTH outside the normal range).
  • Hepatic impairment (ALT or AST outside the normal range).
  • eGFR < 35 mL/min.
  • Severe psychiatric or cognitive disorders that prevent cooperation with the investigators.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site

  • Longhua Hospital Shanghai University of Traditional Chinese Medicine

    Shanghai, 200032

Other trials in China

About this study

Official title: A Prospective, Multicenter, Randomized, Double-Blind Controlled Clinical Study of Quanduzhong Capsules for the Prevention and Treatment of Primary Osteoporosis

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?

Read more

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

Being tested
Quan Duzhong Capsules, Quan Duzhong Capsule Placebo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Quan Duzhong CapsulesDrug

    Also called Du-Zhong Capsules

    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.

  • Quan Duzhong Capsule PlaceboDrug

    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.

Study groups in NCT07895082
Study groupRoleWhat they receive
Quan Duzhong CapsulesExperimentalQuan 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.
Receives: Drug: Quan Duzhong Capsules
PlaceboPlacebo comparatorQuan 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.
Receives: Drug: Quan Duzhong Capsule Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 6 months

Secondary outcomes (11)

  1. Change in Serum Calcium

    Serum calcium measured by laboratory tests. Change from baseline will be calculated.

    Measured: Baseline and 6 months

  2. Change in Serum Phosphorus

    Serum phosphorus measured by laboratory tests. Change from baseline will be calculated.

    Measured: Baseline and 6 months

  3. Change in muscle strength

    Muscle strength is assessed by study-specific measurements during the study.

    Measured: Baseline and 6 months

  4. Change in incidence of falls

    the number and incidence of falls should be recorded during the study.

    Measured: Baseline and 6 months

  5. Change in 25-Hydroxyvitamin D

    Serum 25-hydroxyvitamin D measured by laboratory tests. Change from baseline will be calculated.

    Measured: Baseline and 6 months

  6. Change in Parathyroid Hormone (PTH)

    Serum parathyroid hormone (PTH) measured by laboratory tests. Change from baseline will be calculated.

    Measured: Baseline and 6 months

  7. 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.

    Measured: Baseline and 6 months

  8. 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.

    Measured: Baseline and 6 months

  9. Change in Serum Osteocalcin

    Serum osteocalcin measured by laboratory tests. Change from baseline will be calculated.

    Measured: Baseline and 6 months

  10. 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.

    Measured: Baseline and 6 months

  11. 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.

    Measured: Baseline and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Oct 2026
  2. Study start15 Oct 2026 (estimated)
  3. Primary completion15 Apr 2027 (estimated)
  4. Study completion1 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07895082
Sponsor's protocol ID
LHY-DZJ-OP-202610
Acronym
QZDC-PO
Status last verified
Oct 2026
First submitted
13 Oct 2026
Last updated
26 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
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.

Publications

  • Zhao Y, Wang Q, Liu S, Wang Y, Shu B, Zhao D. Preparation Of Gushukang (GSK) Granules for In Vivo and In Vitro Experiments. J Vis Exp. 2019 May 9;(147). doi: 10.3791/59171.

    PubMed 31132042

  • Tang DZ, Hou W, Zhou Q, Zhang M, Holz J, Sheu TJ, Li TF, Cheng SD, Shi Q, Harris SE, Chen D, Wang YJ. Osthole stimulates osteoblast differentiation and bone formation by activation of beta-catenin-BMP signaling. J Bone Miner Res. 2010 Jun;25(6):1234-45. doi: 10.1002/jbmr.21.

    PubMed 20200936

  • Svedbom A, Ivergard M, Hernlund E, Rizzoli R, Kanis JA. Epidemiology and economic burden of osteoporosis in Switzerland. Arch Osteoporos. 2014;9:187. doi: 10.1007/s11657-014-0187-y. Epub 2014 Jun 27.

    PubMed 24970672

  • Liu M, Zhang Y, Cheng X, Lu Y, Li N, Gong Y, Pei Y, Li C. The effect of age on the changes in bone mineral density and osteoporosis detection rates in Han Chinese men over the age of 50. Aging Male. 2014 Sep;17(3):166-73. doi: 10.3109/13685538.2014.940308. Epub 2014 Jul 16.

    PubMed 25027466

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Quan Duzhong Capsules in people with Primary Osteoporosis, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in bone mineral density (BMD) of the lumbar spine (L1-L4) (time frame: Baseline and 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07895082, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.

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