Clinical trial NCT01665651: Kidney Yin/Yang Replenishment on Patients With Renal Osteodystrophy
Official title: Effect of Kidney Yin/Yang Replenishment on Bone Metabolism in Patients With Renal Osteodystrophy
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Renal Insufficiency, Chronic
Renal Osteodystrophy
Lead sponsor: Shanghai University of Traditional Chinese Medicine
Sponsor class: OTHER
Collaborators: name: Huadong Hospital
name: The First Affiliated Hospital of Anhui University of Chinese Medicine
name: Longhua Hospital
First posted: 2012-08-15
Enrollment: 0
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Patients with serious chronic renal insufficiency usually develop secondary osteoporosis or bone loss, especially those with chronic dialysis, and the degree of bone loss is corrected with decrease of renal function. In traditional Chinese medicine, kidney function is considered to dominate bone development and metabolism. Kidney Yin and Yang replenishment will help improve bone development and metabolism.

Detailed description: In this study patients with chronic renal insufficiency and secondary osteoporosis or bone loss will be evaluated with traditional Chinese medicine standard and allocated into kidney Yin deficiency and kidney Yang deficiency groups. In Yin deficiency group, patients will be divided into Zuogui granules treatment group and placebo group. In Yang deficiency group, patients will be divided into Yuogui granules treatment group and placebo group. All the patients will also accept basic treatment.

After 3-month-treatment, we will detect blood urea nitrogen, creatinine, bone mineral density, bone metabolism markers including FGF23, 1,25(OH)2D3, Osteocalcin, PTH, BALP, serum and urinal Ca, P. We will also perform miRNA array. The data before treatment and after treatment will be compared. The data of treatment groups and placebo groups will also be compared.

Eligibility criteria: Inclusion Criteria:

* chronic renal insufficiency
* bone loss or osteoporosis
* 30-50 years old
* kidney Yin or Yang deficiency evaluated with traditional Chinese medicine
* be willing to and be able to join in the study and signed Informed consent
* have not accepted systematical treatment on bone loss or osteoporosis

Exclusion Criteria:

* allergies
* secondary osteoporosis caused by other diseases.
* postmenopausal women
* mental illness or psychosis
* patients with bone fracture and need surgery treatment
* taking any medicine that will affect bone metabolism for a long time and can not stop
* women during pregnant stage and breast-feed stage

Primary outcomes:
measure: Bone Mineral Density
timeFrame: 3 months
Secondary outcomes:
measure: Kidney Yin and Yang evaluation
timeFrame: 3 months
measure: bone metabolism
timeFrame: 3 months
measure: Blood Urea Nitrogen
timeFrame: 3 months
measure: creatinine
timeFrame: 3 months
Other outcomes:
measure: miRNA array
timeFrame: 3 months
measure: bone morphogenetic protein 7
timeFrame: 3 months
Locations:
city: Hefei
country: China
facility: The first affiliated hospital of Anhui University of TCM
state: Anhui
city: Shanghai
country: China
facility: Huadong hospital affiliated to Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Longhua Hospital affiliated to Shanghai Uni of TCM
state: Shanghai
Study officials:
affiliation: Longhua hospital affiliated to Shanghai Uni of TCM
name: Yongjun Wang, Doctor
role: PRINCIPAL_INVESTIGATOR
References: