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Status unknownNCT02223572Updated Aug 22, 2014

Secondary Fracture Prevention in Patients Who Suffered From Osteoporotic Fracture

An interventional study of hip Xray in Hip Fractures, Osteoporotic Fractures and Osteoporosis, sponsored by pninarotman. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-08-22.

Sponsored by pninarotman · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Aug 2014), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
50
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

Due to its prevalence worldwide, osteoporosis is considered a serious public health concern. The worldwide annual incidence of Osteoporotic fractures is approximately 2 million in the US only.

Hip fracture is associated with serious disability and excess mortality. Studies have shown that an initial osteoporotic fracture is a major risk factor for a new fracture. An increased risk of 14.8% for a secondary hip fracture has been demonstrated in people that have already sustained a fracture in the past 4 years (In average). These data indicate the major opportunity afforded by secondary fracture prevention strategies.

By responding to the first fracture, we can reduce the incidence of second and subsequent fractures. However, even after longer medical follow-up according to regular standard of care, medical treatment and rehabilitation, the medical system has been unable to translate the eminent risk into an effective preventive treatment.

Read the detailed description

Study Objectives:

  • To create a treatment, follow up and rehabilitation protocol for patients who suffered from a hip fracture, in order to prevent a secondary fracture.
  • To demonstrate that a combined treatment from the Hip Fractures Clinic as well as the regular standard treatment and rehabilitation suggested by the Bone Health Clinic (both in addition to standard medication prescribed for osteoporosis) will result in a significant reduction of second and subsequent fractures.

Study Protocol:

  1. The study protocol will begin after the patients, who have been admitted with a primary hip fracture (of osteoporotic nature), were surgically treated (as customary standard of care).
  2. According to hospitalization standard protocol, the patients will be treated with vitamin D and calcium. For the first month the patient will be given a loading dose of 70,000 units. For the next months the patients will receive 50,000-80,000 units per month.

    In addition, the patient will be treated with Calcium Pills (Caltrate TAB 600mg, once a day)

  3. In addition to the clinical customary monitoring tests performed during the hospitalization, Biomarkers and safety assessment will be taken:

    1. Vitamin D
    2. Bone Markers - Bone markers will be taken three days after the patient was admitted, and one more time six months later (as part of follow up visit).
  4. Follow up visits after hospitalization due to surgery for primary hip fracture.

    1. Follow up visits at the Hip Fracture Clinic will occur in intervals of: six weeks, 3 months, 6 months and a year, since the patient had been released from hospitalization. At follow up visit, the patient will be assessed for physical examination, hip X-ray and the rehabilitation progression Questionnaire (HHS).
    2. Follow up visits at the Bone Health Clinic will occur between 6 weeks to 3 months since the patient had been released from hospitalization (as part of regular standard of care).
    3. A 3cc Serum sample will be taken with the purpose to serve on future studies and examine new markers such as bone markers SCLEROSTIN. There will be no further use of these samples. The samples will remain in deep freeze temperature (C˚70-).
02

Conditions studied

  • Hip Fractures
  • Osteoporotic Fractures
  • Osteoporosis
03

In context

Osteoporosis

1,640 studies on the registry are indexed under Osteoporosis; 212 are open to participants now.

This study's planned enrollment of 50 is below the median of 95 across 1,133 interventional studies indexed under Osteoporosis.

Browse Osteoporosis studies →

Lead sponsor

This is the only study on the registry with pninarotman as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adults over 18 years old
  • Patients diagnosed with low energy osteoporotic hip fracture, and was treated under surgery.

Exclusion criteria

Exclusion Criteria:

  • Patients not diagnosed with osteoporosis.
  • Patients diagnosed with high energy osteoporotic hip fracture.
  • Patients that suffered from Multiple Trauma.
  • Patients diagnosed with Metabolic diseases or Genetic diseases.
  • Pregnant women
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
50 participants (estimated)

Study arms

  • Experimental
    osteoporotic hip fracture

    Radiation: hip Xray

Interventions

  • Radiationhip Xray
06

What researchers measure

Primary outcomes

  1. Reduce number of incidents of secondary hip fracture.

    Time frame: 1 year and 6 months

07

Study locations

1 site
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 22, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02223572
Lead sponsor
pninarotman
Collaborators
Meir Medical Center
Responsible party
pninarotman (Depart. of Medicine 'E' Deputy Head, Meir Medical Center) — Sponsor-investigator
First posted
Aug 22, 2014
Start date
Sep 2014
Primary completion
Apr 2016 (estimated)
Completion
May 2016 (estimated)
Last update
Aug 22, 2014

Study contacts

Pnina Rotman, MD
Contact
Pnina.Rotman@clalit.org.il
+972-9-7472671
Eyal Yaacobi, MD
Contact
Eyal.Yaacobi@clalit.org.il
+972-3-9385700
Eyal Yaacobi, M.D.
principal investigator · Meir Medical Center
Pnina Rotman, MD
principal investigator · Meir Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2014. You cannot join it, but the record below documents what was studied.

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