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ENROLLING BY INVITATION

NCT07895082

PHASE3

Quanduzhong Capsules for Primary Osteoporosis

Sponsor: Shanghai University of Traditional Chinese Medicine

View on ClinicalTrials.gov

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 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

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

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

300

Start Date

2026-10-15

Completion Date

2027-05-01

Last Updated

2026-10-26

Healthy Volunteers

Conditions

Primary Osteoporosis

Interventions

DRUG

Quan Duzhong 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.

DRUG

Quan Duzhong Capsule Placebo

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.

Inclusion Criteria * 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 Criteria * 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. * 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.

Locations (1)

Longhua Hospital Shanghai University of Traditional Chinese Medicine

Shanghai, China