Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05571514
Other study ID # 20PH256
Secondary ID ANSM
Status Recruiting
Phase N/A
First received
Last updated
Start date May 12, 2023
Est. completion date November 2028

Study information

Verified date May 2024
Source Centre Hospitalier Universitaire de Saint Etienne
Contact Adamah AMOUZOUGAN, MD
Phone (0)477120595
Email amadah.amouzougan@chu-st-etienne.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Post-menopausal osteoporosis and the resulting fractures are an important cause of disability and loss of independence. They also increase the risk of morbidity and mortality. Given potential side effects, hormone replacement therapy is no longer recommended for menopausal women with risk of becoming osteoporotic. The very significant decrease in the use of these treatments is suspected of contributing to a resurgence in the incidence of osteoporotic fractures, particularly in women before the age of 70. There is a need for prevention of osteoporosis.


Description:

Mother-of-pearl is a candidate for long-term use due to the combination of its effects: calcium supplementation, anti-resorptive activity and osteoanabolic activity. Our hypothesis is that powdered mother-of-pearl supplementation limits bone loss in postmenopausal women with risk of becoming osteoporotic.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date November 2028
Est. primary completion date November 2027
Accepts healthy volunteers No
Gender Female
Age group 50 Years to 65 Years
Eligibility Inclusion Criteria: - Post-menopausal women (50-65y) with risk of becoming osteoporotic - T-score between -1 and -3 - Absence of fragility fractures history Exclusion Criteria: - absence of parathyroid glands (phospho-calcic regulation) - presence of kidney stones - patients who follow a treatment that could interfere with bone metabolism (corticotherapy, menopausal hormonal therapy, anti-oestrogen treatment, non-controlled hyperthyroiditis, hyper- and hypothyroiditis) - bone diseases (Paget'disease, osteomalacia) - chronic alcoholism

Study Design


Intervention

Dietary Supplement:
Mother-of-pearl
The mother-of-pearl, derived from the inner shell of marine molluscs, is composed of calcium carbonate and organic compounds, some of which peptides are active on the bone. The mineralization inducing activity of the molecules extracted from the mother-of-pearl has been shown in vitro. Mother-of-pearl extract also contains molecules that inhibit the resorption activity of osteoclasts. Mother-of-pearl compounds can thus slow bone remodelling as showed in an ovariectomy-induced osteoporosis model in rat, where mother-of-pearl supplementation showed a better effect on limitation of bone loss than calcium carbonate supplementation.
Calcium Carbonate
Calcium carbonate is a source of calcium.

Locations

Country Name City State
France Hôpital Gabriel Montpied Clermont-Ferrand
France Clinique Universitaire de Rhumatologie Grenoble
France CH Emile Roux Le Puy-en-Velay
France Hôpital Edouard Herriot Lyon
France CH Roanne Roanne
France CHU Saint-Etienne Saint-Étienne

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Universitaire de Saint Etienne Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change in bone loss at lumbar site Demonstrate that oral mother-of-pearl powder supplementation, for 1 year, reduces bone loss at lumbar site in postmenopausal women with risk of becoming osteoporotic, in a better way than oral supplementation with pure CaCO3.
Measurement of the change in BMD will be performed by DXA (dual X-ray absorptiometry bone densitometry)
Baseline from 12 months
Secondary Tolerance to oral mother-of-pearl powder supplementation Tolerance will be assessed by collecting digestive disorders Baseline from 12 months
Secondary Change in bone loss at the upper end of the femur Evaluate the impact of oral mother-of-pearl powder supplementation, compared to oral supplementation with pure CaCO3, for 1 year, in postmenopausal women on the bone loss at the upper end of the femur Measurement of the change in BMD will be performed by DXA (dual X-ray absorptiometry bone densitometry) Baseline from 12 months
Secondary Change in bone remodeling of the femur Evaluate the impact of oral mother-of-pearl powder supplementation, compared to oral supplementation with pure CaCO3, for 1 year, in postmenopausal women on the bone remodeling Measurement of the change in BMD will be performed by measurement CTX (serum Collagen-telopeptide) Baseline from 12 months
See also
  Status Clinical Trial Phase
Completed NCT01674621 - Phase 2 Study of BA058 (Abaloparatide) Transdermal Delivery in Postmenopausal Women With Osteoporosis Phase 2
Completed NCT01732770 - Safety and Efficacy Study to Evaluate Denosumab Compared With Zoledronic Acid in Postmenopausal Women With Osteoporosis Phase 4
Completed NCT00377234 - A Study Comparing Monthly Boniva (Ibandronate) and Weekly Risedronate in Women With Post-Menopausal Osteoporosis. Phase 4
Completed NCT00048074 - DIVA Study - A Study of Different Regimens of Intravenous Administration of Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis Phase 3
Completed NCT02347865 - Characteristics and Management of Postmenopausal Women With Osteoporosis Treated With Prolia® in France
Completed NCT00545480 - SUMMIT Study: A Study of Persistence to Bonviva (Ibandronate) Once Monthly in Women With Post-Menopausal Osteoporosis. Phase 4
Completed NCT00303485 - A Study of Bone Turnover Markers in Post-Menopausal Women With Osteoporosis Treated With Monthly Boniva (Ibandronate) Phase 4
Active, not recruiting NCT05332626 - Lactobacillus Acidophilus and Postmenopausal Osteoporosis Women N/A
Completed NCT00545090 - ExBonAdAsia Study: A Study of Once Monthly Bonviva (Ibandronate) in Women With Post-Menopausal Osteoporosis. Phase 4
Completed NCT02598934 - A Study of Ibandronate (Boniva) to Evaluate Bone Turnover Markers in Women With Treatment-Naive Postmenopausal Osteoporosis Phase 4
Completed NCT01290094 - A Study of Bonviva/Boniva (Ibandronate) in Biphosphonate-Naïve Women With Post-Menopausal Osteoporosis Phase 3
Completed NCT00048061 - MOBILE Study - A Study of Bonviva (Ibandronate) Regimens in Women With Post-Menopausal Osteoporosis Phase 3