National Guideline on Management of Osteoporosis at Hospital Level Preventative Measures at primary Level

Foreword

Osteoporosis is often known as the "silent thief" because bone loss occurs without symptoms. Bone loss leads to increased bone fragility and risk of fracture particularly of hip, spine and wrist. The reduced quality of life for those with Osteoporosis is enormous. Osteoporosis can result in disfigurement, lowered self-esteem, reduction or loss of mobility and decreased independence.

Without effective action on osteoporosis prevention and treatment, the cost of treating osteoporosis and the fractures it causes, given the increasing population of older people, will surely rise.

We advocate preventative and promotive health and I believe that early diagnosis and interventions are more cost-effective than treatment of the advanced disease.

Finally, I want to take this opportunity and salute all those who were involved in the process of developing this guideline, both from government and civil society.

Dr Manto Tshabalala-Msimang
Minister of Health

Guideline on Management of Osteoporosis

Introduction

Osteoporosis is defined as a systemic skeletal disease characterised by low bone mass, measured as bone mineral density (BMD) and micro-architectural deterioration of bone tissue (difficult to assess) with consequent increase in bone fragility and susceptability to fractures, which typically involves the wrist, spine or hip.

Bone strength is largely determined by bone mass (BMD),which is a function of:

  1. peak bone mass attained during early adulthood
  2. age-related bone loss
  3. total duration of loss

Peak bone mass is mainly determined by heredity and gender, while age-related (involutional) bone loss results mainly from menopausal hormone deficiency and ageing. Emphasis on early diagnosis and interventions will be more cost-effective than the treatment of advanced disease. Although osteoporosis is permanent condition, the disease can be prevented and progression can be retarded. The condition can improve dramatically with effective treatment.

Osteoporosis is a common costly bone disease, which carries a significant morbidity, mortality and disability and is frequently undiagnosed. Although the disease occurs in ll populations, it is currently perceived to be less common in men, African people and women of heavier build. A third of females over 60 years of age globally, have had at least one vertebral (spinal) fracture and a quarter of women aged 80 years have had a hip fracture, because of osteoporosis. A lifetime risk of fracture in Caucasoid women is 30 -40%. The prognosis after a fracture is poor ±20%increase in mortality risk after one year and more than 50%will never regain functional ability to lead an independent life.

Bone loss (resorption) is an inevitable process of ageing. However taking various precautions can slow down the rate of bone loss. In menopause the production of the hormone oestrogen falls, which leads to an accelerated decline of bone mass and an increased risk of developing osteoporosis. Women who smoke tend to reach the menopause earlier than those who do not, and so are more susceptible to osteoporosis. Women at particular risk are those who have had an oophorectomy (removal of ovaries) before the menopause (especially before 45 years of age)

Objecitves of the Guidelines are to:

Scope of the Guideline

Target population for:

Management of Guideline

Resources

Human Resources

Priority Issues to be Addresses to Assisrt Implementation

Factors for Increased Risk of Osteoporosis

Modifiable Risk Factors

Non Modifiable Risk Factors

Risk factors for falls are:

Table 1: World Health Organisation’s classification of osteoporosis

(1) Normal A value for BMD or Bone Mineral Content (BMC) within 1 SD of the young adult reference mean
(2) Osteopenia (low bone mass) A BMD or BMC value of more than 1 SD, but less than 2.5 SD below the young adult mean
(3) Osteoporosis BMD or BMC more than 2.5 SD below the young adult mean
(4) Established osteoporosis (severe) BMD or BMC more than 2.5 SD below young adult mean plus one or more fragility fractures

WHO (1994)has proposed four diagnostic categories based on a subject ’s Bone Mineral Density (BMD) expressed in relation to the young adult reference mean (T-score) and the presence of fragility fractures.

These diagnostic criteria have limitations:

Also the diagnostic criteria is based on healthy postmenopausal Caucasian women. Extrapolations of these criteria to other populations assessed with different techniques and different sites should be cautioned against diagnosis of low BMD (osteoporosis/ osteopenia /or identifying of persons at risk of future fractures.

Referral criteria

A case finding approach should be followed. Unselected screening is not recommended.

Assessment of the patient

History, physical examination and laboratory assessment should aim to:

Measurement of BMD

Biomedical investigations

Bone biopsy is only recommended where osteomalacia is suspected (gastro-intestinal pathology, use of anti-epileptics, poor nutrition) or if severe osteopenia remains unexplained.

Management

The four WHO diagnostic categories should not be regarded as intervention thresholds for all. Intervention is indicated for categories (iii) and (iv), unless the patient has a limited life expectancy, where intervention is then not indicated.

Prevention of Osteoporosis:

Non Pharmalogical Measures

Prevention of osteoporosis focuses on increasing peak bone mass, which is usually reached between the ages 30-35 years, reducing bone loss in the later years. Peak bone mass is mainly determined by heredity and gender, but nutrition, physical activity, pubertal development and general health may have considerable influence. Age related bone loss appears to result from menopausal hormone deficiency, progressive age-related osteoblast incompetence and superimposed risk factors.

Prevention strategies

The latter is the only viable option and a combination of diagnostic methodology is the best option to identify the "at high-risk group ".

Diet

A balanced diet rich in calcium, energy and vitamins and without excess protein is recommended.

The role of calcium in the prevention and treatment of osteoporosis

Calcium requirements change during the different life stages. If dietary calcium is insufficient in childhood, the skeleton will not develop to its full potential and strength; hence the risk of osteoporosis will be greater in later life.

As an individual ages the body ’s ability to absorb calcium declines, particularly from the age of 50 years onwards. Calcium deficiency has a more pronounced effect on age-related bone loss. Calcium requirements of older people are thus higher than those of younger adults and interventions later in life seem to be more beneficial. An adequate dietary intake of calcium throughout life can reduce the risk of osteoporosis significantly.

Calcium supplements can be useful if sufficient calcium cannot be obtained from dietary sources. Calcium supplementation also has a role to play in the treatment of osteoporosis but cannot substitute or replace hormonal or other non-hormonal forms of therapy for the prevention or management of osteoporosis.

Examples of calcium-rich foods

Foods that contain significant amounts of calcium content are:

High dosages of fibre can reduce the absorption of calcium,therefore fibre and calcium should not be taken simultaneously.

Vitamin D

To optimise bone health,scientific findings support the intake of calcium and vitamin D. Vitamin D increases the intestinal absorption of calcium and phosphate. It also aids bone mineralisation but in supra-physiological dosage may cause bone resorption.High doses of vitamin D can result in serious hypocalcaemia,hyper-calciuria and renal function impairment. Monitoring is therefore necessary.

Vitamin D is obtained from two sources: Dietary intake and cutaneous production. Dietary intake and absorption ability declines with age as well as the synthetic capacity of the skin.

In Southern Africa vitamin D supplementation is seldom necessary, except for housebound people. But recent studies here have shown poor provitamin D activation in the Western Cape.

Recommended

Adequate intake of vitamin D is:

50 -70 years -400 IU daily
>70 years -800 IU daily

Alcohol consumption

Chronic alcohol consumption decreases bone strength and increases the risk of falling. The risk of hip fractures doubles when more than 8 tots of alcohol is taken per week. Moderate alcohol intake in postmenopausal women has been associated with increased BMD, but the reasons remain unclear. Alcohol consumption should not be promoted because even moderate alcohol intake in premenopausal women and in men is risk factor.

Smoking

Smoking decreases bone mass, increases the metabolism of oestrogen and lowers the intestinal absorption of calcium. Stop smoking!

Physical exercise

Participation in moderate physical activities between the ages 5 -14 years increases bone density and consequently bone mass of the hip,arm and spine of children. Any weight-bearing activities especially walking is beneficial for bone strength in ll ages. on-weight bearing activity maintains neuro muscular performance and improves muscular strength, stability and balance, which help to reduce falls and risk of osteoporosis related injury. Exercise like marathon running and ballet dancing coupled with severe calory restrictions may have adverse effects on bone health.

Refer to guideline on Promotion of Active Ageing in Older Persons at Primary Level and National guideline on Prevention of Falls of Older Persons

Drug usage

Treatment by Pharmalogical Agents

Treatment objectives

When to treat

Decisions about the need to treat will depend on:

Another indication for the implementation of treatment is for women with a T-score of more than 2 SD below the young adult mean. A T-score 2 coincides with the so-called "fracture threshold ".

Pharmacological Management of Osteoporosis (WHO Categories 3 and 4)

Calcium

A daily dietary intake of 1000 -1500 mg is recommended. If intake or absorption is impaired, provide with supplement.

Vitamin D

Routine supplementation is not recommended. In older persons, especially those with limited mobility and institutionalised persons, prophylactic dose of 400 -800 IU is proposed where a vitamin D deficiency is present,50 000 IU every two to four weeks is recommended.

NOTE In the latter dosage, monitor urinary calcium and vitamin D derivatives to void hypercalcaemia, hypercalciuria and renal failure.

Hormonal Replacement Therapy (HRT)

Long-term treatment (10 years and more) is necessary for the decreased, risk of fractures of the spine,hip, wrist, and myocardial infarction. A decrease in morbidity of up to 50%could be expected with effective treatment. Hormone replacement therapy reduces the rate of osteoporosis spine (60%)and hip fractures (30%) significantly. The response is dose-related, and the route is unimportant.

  Management Comments
Drug treatment Hormone replacement therapy (HRT) Intact uterus (no hysterectomy): NB Progestogen must be added always with intact uterus

Oestrogen/progestogen combination e.g.

Norgestrel +estradiol,oral,1mg/2mg daily

Sequentially oestrogen and progesterone Oestrogen is given for 21 -28 days and progestogen for the last 10 -14 days HRT should be continued for at least

OR

10-15 years from diagnosis.

Single oral preparations.

Continuous progestogen administration requires a minimum of 2.5 mg medroxy-progestrone acetate daily

Uterus absent (post hysterectomy):Estradiol valerate,oral,1-2mg daily

OR

Oestrogen conjugated,oral,0.625mg - 1.25mg daily on a cyclical basis.0.625mg adjusted to a minimum effective dose to prevent postmenopausal bone loss

OR

Ethinylestradiol,oral,0.02mg -0.05mg daily

The most important contraindication for HRT is previous hormone dependent malignant tumour. In all instances, consult with a specialist.

In women with an intact uterus, combination therapy should be used to minimise the risk of uterine cancer

HRT should also target patients >65 years of age when it is likely to be most cost-effective

  Selective oestrogen receptor modulators e.g. Raloxifene

Testosterone
Depo Testosterone
200 mg IMI /3 weekly

Proposed for those women at risk of endometrial or breast cancer

Only for hypgonadal males

  Bisphosphonates,e.g. Alendronic acid,oral,10mg daily to be  taken with water only on an empty stomach. Delay eating and drinking for 30 minutes or bone specific drug is required in healthy persons Only to be initiated by specialists e.g. geriatricians,gynaecologists,endocronologists.

This may be indicated when absolute contraindications for oestrogens exist. Beneficial for all ages

  Anabolic steroids Should be reserved for patient with advanced osteoporosis. To be prescribed by a specialist especially in frail older persons and acute vertebral fracture.
Pain control Paracetamol tab.500-1 000mg if necessary for 2 -3 weeks

Morfine

Intense pain or vertebral fractures.

Monitoring of Therapy

Then after stabilisation annually (up to 2 years of initiation)

Acknowldgements: Osteoporosis

The Department of Health wishes to thank all the people who were involved in the development of the Guideline on Management of Osteoporosis t Hospital Level Preventative Measures at Primary Level.

Special thanks to the following stakeholders:


National Guideline on Management of Osteoporosis at Hospital Level Preventative Measures at primary Level

Compiled by the Directorate: Chronic Diseases,

Disabilities and Geriatrics

December 2001