Quan Duzhong Capsules compared with placebo for primary osteoporosis
Tests Quan Duzhong Capsules against placebo in adults with primary osteoporosis.
Plain-language title generated from the registry record
Registry title: Quanduzhong Capsules for Primary Osteoporosis
Key facts
- Where
- Shanghai, ChinaSee the site
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07895082, who can take part
Where in China
- LongHua Hospital Shanghai University of Traditional Chinese MedicineShanghai, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Shanghai University of Traditional Chinese Medicine
- Trial code
- NCT07895082
- Record updated
- 26 October 2026
- Original description
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:Read full original descriptionShow less
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?
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
Inclusion: 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.
Exclusion: Use of any of the following medications affecting bone metabolism:; 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; 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; History of hip fracture; 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); History of taking Quan Duzhong Capsules within the past 6 months; Severe psychiatric or cognitive disorders that prevent cooperation with the investigators; Known hypersensitivity to calcium and vitamin D preparations or the investigational traditional Chinese medicine preparation(s); Severe vitamin D deficiency (serum 25-hydroxyvitamin D < 25 nmol/L [10 ng/mL]); Hepatic impairment (ALT or AST outside the normal range); eGFR < 35 mL/min; Intravenous bisphosphonates within 5 years before enrollment; Hypercalcemia or hypocalcemia; Uncontrolled hypothyroidism or hyperthyroidism (TSH outside the normal range); Uncontrolled hypoparathyroidism or hyperparathyroidism (PTH outside the normal range).